fentanyl and Low Back Ache

fentanyl has been researched along with Low Back Ache in 29 studies

Fentanyl: A potent narcotic analgesic, abuse of which leads to habituation or addiction. It is primarily a mu-opioid agonist. Fentanyl is also used as an adjunct to general anesthetics, and as an anesthetic for induction and maintenance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1078)
fentanyl : A monocarboxylic acid amide resulting from the formal condensation of the aryl amino group of N-phenyl-1-(2-phenylethyl)piperidin-4-amine with propanoic acid.

Research

Studies (29)

Authors

Clinical Trials (8)

Trial Overview

Trial Outcomes

Average Pain Intensity Before the Start of Tapentadol Treatment

"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine." (NCT00986258)
Timeframe: Baseline

Change in Average Pain Intensity After 12 Weeks of Tapentadol Prolonged Release Treatment.

"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity." (NCT00986258)
Timeframe: Baseline; End of Week 12 (12 weeks)

Change in Average Pain Intensity After 6 Weeks of Tapentadol Prolonged Release Treatment.

"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A negative value indicates a reduction in pain intensity from the baseline average pain intensity." (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 weeks)

Mean Equipotency Ratio of Tapentadol Compared to Buprenorphine

Tapentadol was compared to Buprenorphine with Buprenorphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Buprenorphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Buprenorphine. (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 Weeks)

Mean Equipotency Ratio of Tapentadol Compared to Fentanyl

Tapentadol was compared to Transdermal Fentanyl with Fentanyl set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Transdermal Fentanyl was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Fentanyl. (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 Weeks)

Mean Equipotency Ratio of Tapentadol Compared to Hydromorphone

Tapentadol was compared to Hydromorphone with Hydromorphone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Hydromorphone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Hydromorphone. (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 Weeks)

Mean Equipotency Ratio of Tapentadol Compared to Morphine

Tapentadol was compared to Morphine with Morphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Morphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Morphine. (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 Weeks)

Mean Equipotency Ratio of Tapentadol Compared to Oxycodone

Tapentadol was compared to Oxycodone with Oxycodone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Oxycodone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Oxycodone. (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 Weeks)

Number of Participants That Responded to Treatment

Participants were considered responders if they reported the same or less average pain intensity over a 3 day period (NRS-3) after 6 weeks of tapentadol prolonged release treatment compared to their previous analgesic treatment (over a 3 day period on the Numeric Rating Scale) at Week 6 compared with Week-1. (NCT00986258)
Timeframe: 6 weeks

painDETECT Assessment at Baseline

"The painDETECT questionnaire was used to determine the possibility of the presence of a neuropathic pain component. It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear." (NCT00986258)
Timeframe: Baseline

painDETECT Assessment for Participants After 12 Weeks of Tapentadol Prolonged Release Treatment

"The baseline painDETECT score was reassessed at the end of Week 12.~It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear." (NCT00986258)
Timeframe: End of Week 12

painDETECT Assessment for Participants After 6 Weeks of Tapentadol Prolonged Release Treatment

"The baseline painDETECT score was reassessed at the end of Week 6.~It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear." (NCT00986258)
Timeframe: End of Week 6

Change in the Health Survey Scores Form (SF-36)

The Scores Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline. (NCT00986258)
Timeframe: Baseline; End of Week 12 (12 Weeks)

Change in the Health Survey Scores Form (SF-36)

The Scores Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline. (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 Weeks)

Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score

"All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.~Results are reported as the mean (average) for each neuropathic symptom in a sub-scale.~The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group)." (NCT00986258)
Timeframe: End of Week 12

Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score

"All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.~Results are reported as the mean for each neuropathic symptom in a sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group)." (NCT00986258)
Timeframe: End of Week 6

Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score

"All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.~Results are reported as the mean for each neuropathic symptom in the sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group)." (NCT00986258)
Timeframe: Baseline

Patient Global Impression of Change

In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse. (NCT00986258)
Timeframe: Baseline; End of Week 12 (12 Weeks)

Patient Global Impression of Change

In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse. (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 Weeks)

Oswestry Disability Index

Measure of functional capacity on a scale ranging from 0% to 100%, with 0% signifying no disability (NCT01472835)
Timeframe: 1-month

Pain Score

0-10 numerical rating scale (NRS) pain scale. 0 being no pain and 10 being the worst possible pain. (NCT01472835)
Timeframe: 1-month

Pain Score

pain diary using 0-10 scale, with 0 being no pain and 10 being the worst pain imaginable (NCT01472835)
Timeframe: through 6 hours after injection

Procedure-related Pain Score

0-10 pain scale, with 0 being no pain and 10 being the worst pain imaginable (NCT01472835)
Timeframe: 1 day

Satisfaction

5-point Likert scale. The scale is from 1-5. 1 being very unsatisfied and 5 being very satisfied. (NCT01472835)
Timeframe: 1 day

Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy

Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted. (NCT01008553)
Timeframe: Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)

Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period

The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain. (NCT01008553)
Timeframe: Day 1 and 85 or final evaluation (double-blind period)

Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period

The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain. (NCT01008553)
Timeframe: Day 1 and 29 or final evaluation (Titration period)

Number of Doses of Rescue Treatment Per Day - Double-Blind Period

If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. (NCT01008553)
Timeframe: Day 1 and 85 or final evaluation (double-blind period)

Number of Doses of Rescue Treatment Per Day - Titration Period

If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. (NCT01008553)
Timeframe: Day 1 and 29 or final evaluation (Titration period)

Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period

"The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: Extremely satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied and Dissatisfied very much. The results were reported as Category 1 = At least Neither satisfied nor dissatisfied, which included participants with general evaluation of Extremely satisfied to Neither satisfied nor dissatisfied, and Category 2 = At least Satisfied, which included participants with general evaluation of Extremely satisfied to Satisfied." (NCT01008553)
Timeframe: Day 1 and 85 or final evaluation (double-blind period)

Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period

"The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: Extremely satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied and Dissatisfied very much. The results were reported as Category 1 = At least Neither satisfied nor dissatisfied, which included participants with general evaluation of Extremely satisfied to Neither satisfied nor dissatisfied, and Category 2 = At least Satisfied, which included participants with general evaluation of Extremely satisfied to Satisfied." (NCT01008553)
Timeframe: Day 1 and 29 or final evaluation (Titration period)

Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period

Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective. (NCT01008553)
Timeframe: Day 1 and 85 or final evaluation (double-blind period)

Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period

Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective. (NCT01008553)
Timeframe: Day 29 or final evaluation (Titration period)

Pain Visual Analog Scale (VAS) Score - Double-Blind Period

"The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a 100-millimeter (mm) VAS scale by drawing a slash. The left margin (0 mm) was considered No pain at all, and the right margin (100 mm) was considered Severer pain than this is inconceivable. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of titration period and during 3 days before the end of double-blind period was reported." (NCT01008553)
Timeframe: Day 27-29 (Titration period) and Day 83-85 (double-blind period)

Pain Visual Analog Scale (VAS) Score - Titration Period

"The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a 100-millimeter (mm) VAS scale by drawing a slash. The left margin (0 mm) was considered No pain at all, and the right margin (100 mm) was considered Severer pain than this is inconceivable. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of Screening period and during 3 days before the end of titration period was reported." (NCT01008553)
Timeframe: Day 12-14 (Screening period) and Day 27-29 (Titration period)

Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Double-Blind Period

The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state. (NCT01008553)
Timeframe: Day 1 and 85 or final evaluation (double-blind period)

Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Titration Period

The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state. (NCT01008553)
Timeframe: Day 1 and 29 or final evaluation (Titration period)

Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy

Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted. (NCT01008618)
Timeframe: Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)

Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period

The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain. (NCT01008618)
Timeframe: Day 1 and 85 or final evaluation (double-blind period)

Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period

The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain. (NCT01008618)
Timeframe: Day 1 and 29 or final evaluation (Titration period)

Number of Doses of Rescue Treatment Per Day - Double-Blind Period

If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported. (NCT01008618)
Timeframe: Day 1 and 85 or final evaluation (double-blind period)

Number of Doses of Rescue Treatment Per Day - Titration Period

If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported. (NCT01008618)
Timeframe: Day 1 and 29 or final evaluation (Titration period)

Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period

"The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: Extremely satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied and Dissatisfied very much. The results were reported as Category 1 = At least Neither satisfied nor dissatisfied, which included participants with general evaluation of Extremely satisfied to Neither satisfied nor dissatisfied, and Category 2 = At least Satisfied, which included participants with general evaluation of Extremely satisfied to Satisfied." (NCT01008618)
Timeframe: Day 1 and 85 or final evaluation (double-blind period)

Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period

"The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: Extremely satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied and Dissatisfied very much. The results were reported as Category 1 = At least Neither satisfied nor dissatisfied, which included participants with general evaluation of Extremely satisfied to Neither satisfied nor dissatisfied, and Category 2 = At least Satisfied, which included participants with general evaluation of Extremely satisfied to Satisfied." (NCT01008618)
Timeframe: Day 1 and 29 or final evaluation (Titration period)

Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period

Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective. (NCT01008618)
Timeframe: Day 1 and 85 or final evaluation (double-blind period)

Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period

Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective. (NCT01008618)
Timeframe: Day 29 or final evaluation (Titration period)

Pain Visual Analog Scale (VAS) Score - Double-Blind Period

"The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a 100-millimeter (mm) VAS scale by drawing a slash. The left margin (0 mm) was considered No pain at all, and the right margin (100 mm) was considered Severer pain than this is inconceivable. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of titration period and during 3 days before the end of double-blind period was reported." (NCT01008618)
Timeframe: Day 27-29 (Titration period) and Day 83-85 (double-blind period)

Pain Visual Analog Scale (VAS) Score - Titration Period

"The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a 100-millimeter (mm) VAS scale by drawing a slash. The left margin (0 mm) was considered No pain at all, and the right margin (100 mm) was considered Severer pain than this is inconceivable. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of Screening period and during 3 days before the end of titration period was reported." (NCT01008618)
Timeframe: Day 12-14 (Screening period) and Day 27-29 (Titration period)

Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Double-Blind Period:

The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state. (NCT01008618)
Timeframe: Day 1 and 85 or final evaluation (double-blind period)

Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Titration Period

The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state. (NCT01008618)
Timeframe: Day 1 and 29 or final evaluation (Titration period)

Trials

18 trials available for fentanyl and Low Back Ache

Other Studies

11 other studies available for fentanyl and Low Back Ache