Effects of functional taping compared with sham taping and minimal intervention on pain intensity and static postural control for patients with non-specific chronic low back pain: a randomised clinical trial protocol

Objectives. This prospective, randomized clinical trial (RCT) was designed to investigate the feasibility and effects of a 4-week auricular point acupressure (APA) for chronic low back pain (CLBP).Methods. Participants were randomized to either true APA (true acupoints with taped seeds on the designated ear points for CLBP) or sham APA (sham acupoints with taped seeds but on different locations than those designated for CLBP). The duration of treatment was four weeks. Participants were assessed before treatment, weekly during treatment, and 1 month following treatment.Results. Participants in the true APA group who completed the 4-week APA treatment had a 70% reduction in worst pain intensity, a 75% reduction in overall pain intensity, and a 42% improvement in disability due to back pain from baseline assessment. The reductions of worst pain and overall pain intensity in the true APA group were statistically greater than participants in the sham group(P<0.01)at the completion of a 4-week APA and 1 month followup.Discussion. The preliminary findings of this feasibility study showed a reduction in pain intensity and improvement in physical function suggesting that APA may be a promising treatment for patients with CLBP.

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Results of a feasibility randomised clinical trial on pain education for low back pain in Nepal: the Pain Education in Nepal-Low Back Pain (PEN-LBP) feasibility trial

BMJ Open ◽

10.1136/bmjopen-2018-026874 ◽

2019 ◽

Vol 9 (3) ◽

pp. e026874 ◽

Cited By ~ 8

Author(s):

Saurab Sharma ◽

Mark P Jensen ◽

G Lorimer Moseley ◽

J Haxby Abbott

Keyword(s):

Clinical Trial ◽

Low Back Pain ◽

Back Pain ◽

Pain Intensity ◽

Outcome Measures ◽

Randomised Clinical Trial ◽

Education Intervention ◽

Low Back ◽

Pain Education ◽

Pain Catastrophising

ObjectivesThe aims of this study were to: (1) develop pain education materials in Nepali and (2) determine the feasibility of conducting a randomised clinical trial (RCT) of a pain education intervention using these materials in Nepal.DesignA two-arm, parallel, assessor-blinded, feasibility RCT.SettingA rehabilitation hospital in Kathmandu, Nepal.ParticipantsForty Nepalese with non-specific low back pain (mean [SD] age 41 [14] years; 12 [30%] women).InterventionsEligible participants were randomised, by concealed, 1:1 allocation, to one of two groups: (1) a pain education intervention and (2) a guideline-based physiotherapy active control group intervention. Each intervention was delivered by a physiotherapist in a single, 1-hour, individualised treatment session.Primary outcome measuresThe primary outcomes were related to feasibility: recruitment, retention and treatment adherence of participants, feasibility and blinding of outcome assessments, fidelity of treatment delivery, credibility of, and satisfaction with, treatment. Assessments were performed at baseline and at 1 week post-treatment.Secondary outcome measuresPain intensity, pain interference, pain catastrophising, sleep disturbance, resilience, global rating of change, depression and quality of life. Statistical analyses were conducted blind to group allocation.ResultsForty participants were recruited. Thirty-eight participants (95%) completed the 1-week post-treatment assessment. Most primary outcomes surpassed the a priori thresholds for feasibility. Several findings have important implications for designing a full trial. Secondary analyses suggest clinical benefit of pain education over the control intervention, with larger decrease in pain intensity (mean difference=3.56 [95% CI 0.21 to 6.91]) and pain catastrophising (mean difference=6.16 [95% CI 0.59 to 11.72]) in the pain education group. Pain intensity would seem an appropriate outcome for a full clinical trial. One minor adverse event was reported.ConclusionWe conclude that a full RCT of pain education for back pain in Nepal is feasible and warranted.Trial registration numberNCT03387228; Results.

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