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Dry needling in addition to standard physical therapy treatment for sub-acromial pain syndrome: a randomized controlled trial protocol.

ABSTRACT: BACKGROUND:Trigger point dry needling interventions are utilized by physical therapists to manage shoulder pain. Observational studies have shown positive short-term outcomes in patients with subacromial pain syndrome receiving trigger point dry needling. However, little research has been done to evaluate the long-term effectiveness of trigger point dry needling specifically as it compares to other commonly utilized interventions such as exercise and manual therapy. The purpose of this study is to assess the additive short and long-term effectiveness of trigger point dry needling to a standard physical therapy approach of manual therapy and exercise for patients with subacromial pain syndrome. METHODS:This multicenter randomized trial with 3 arms was designed following the standard protocol items for randomized interventional trials. Results will be reported consistent with the consolidated standards of reporting trials guidelines. 130 participants will be randomized to receive standard PT interventions alone (manual therapy and exercise), standard PT and trigger point dry needling or standard PT and sham trigger point dry needling. The primary outcome measures will be the Shoulder Pain and Disability Index and Patient Reported Outcomes Measurement Information Systems (PROMIS-57) scores collected at baseline, 6-weeks, 6-months and one year. Healthcare utilization will be collected for 12 months following enrollment and groups analyzed for differences. DISCUSSION:It is not known if trigger point dry needling provides long-term benefit for individuals with subacromial pain syndrome. This study will help determine if this intervention provides additive benefits over those observed with the commonly applied interventions of exercise and manual therapy. TRIAL REGISTRATION:Identifier: NCT03442894 (https://clinicaltrials.gov/ct2/show/NCT03442894) on 22 February 2018.

SUBMITTER: Hando BR

PROVIDER: S-EPMC6630109 | biostudies-literature | 2019 Jul - Aug

REPOSITORIES: biostudies-literature

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Dry needling in addition to standard physical therapy treatment for sub-acromial pain syndrome: a randomized controlled trial protocol.

Hando Ben R BR Rhon Daniel I DI Cleland Joshua A JA Snodgrass Suzanne J SJ

Brazilian journal of physical therapy 20181106 4

<h4>Background</h4>Trigger point dry needling interventions are utilized by physical therapists to manage shoulder pain. Observational studies have shown positive short-term outcomes in patients with subacromial pain syndrome receiving trigger point dry needling. However, little research has been done to evaluate the long-term effectiveness of trigger point dry needling specifically as it compares to other commonly utilized interventions such as exercise and manual therapy. The purpose of this s ...[more]

PMID: 30455091

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Project description:BACKGROUND:Neck pain is a costly and common problem. Current treatments are not adequately effective for a large proportion of patients who continue to experience recurrent pain. Therefore, new treatment strategies should be investigated in an attempt to reduce the disability and high costs associated with neck pain. Dry needling is a technique in which a fine needle is used to penetrate the skin, subcutaneous tissues, and muscle with the intent to mechanically disrupt tissue without the use of an anesthetic. Dry needling is emerging as a treatment modality that is widely used clinically to address a variety of musculoskeletal conditions. Recent studies of dry needling in mechanical neck pain suggest potential benefits, but do not utilize methods typical to clinical practice and lack long-term follow-up. Therefore, a clinical trial with realistic treatment time frames and methods consistent with clinical practice is needed to examine the effectiveness of dry needling on reducing pain and enhancing function in patients presenting to physical therapy with mechanical neck pain. OBJECTIVE:The aim of this trial will be to examine the short- and long-term effectiveness of dry needling delivered by a physical therapist on pain, disability, and patient-perceived improvements in patients with mechanical neck pain. METHODS:We will conduct a randomized, double-blind, placebo-controlled trial in accordance with the CONSORT guidelines. A total of 76 patients over the age of 18 with acute or chronic mechanical neck pain resulting from postural dysfunction, trauma, or insidious onset who are referred to physical therapy will be enrolled after meeting the eligibility criteria. Subjects will be excluded if they have previous history of surgery, whiplash in the last 6 weeks, nerve root compression, red flags, or contraindications to dry needling or manual therapy. Participants will be randomized to receive (1) dry needling, manual therapy, and exercise or (2) sham dry needling, manual therapy, and exercise. Participants will receive seven physical therapy treatments lasting 45 minutes each over a maximum of 4 weeks. The primary outcome will be disability as measured by the Neck Disability Index. Secondary outcomes include the following: pain, patient-perceived improvement, patient expectations, and successful blinding to the needling intervention. Outcome measures will be assessed at 4 weeks, 6 months, and 12 months by an assessor who is blind to the group allocation of the participants to determine the short- and long-term treatment effects. We will examine the primary aim with a two-way, repeated-measures analysis of variance with treatment group as the between-subjects variable and time as the within-subjects variable. The hypothesis of interest will be the two-way group by time interaction. An a priori alpha level of .05 will be used for all analyses. RESULTS:Recruitment is currently underway and is expected to be completed by the end of 2017. Data collection for long-term outcomes will occur throughout 2017 and 2018. Data analysis, preparation, and publication submission is expected to occur throughout the final three quarters of 2018. CONCLUSIONS:The successful completion of this trial will provide evidence to demonstrate whether dry needling is effective for the management of mechanical neck pain when used in a combined treatment approach, as is the common clinical practice. TRIAL REGISTRATION:ClinicalTrials.gov NCT02731014; https://clinicaltrials.gov/ct2/show/NCT02731014 (Archived by WebCite at http://www.webcitation.org/6ujZgbhsq).

Project description:BackgroundBoth manual therapy techniques and dry needling have shown to be effective treatment options for the treatment of plantar heel pain; however, in recent years, other techniques based on dry needling (DN), such as percutaneous needle electrolysis (PNE), have also emerged. Currently, PNE is being used in clinical practice to manage myofascial trigger points, despite the lack of studies comparing the effects of this technique over dry needling. Therefore, the aim of this randomized controlled study is to compare the effectiveness of DN versus PNE for improving the level of pain experienced by patients suffering from plantar heel pain provoked by myofascial trigger points.MethodsA randomized controlled trial will be conducted with blinded participants and outcome assessors. A sample of 94 patients with a medical diagnosis of plantar heel pain will be recruited and divided into two treatment groups. Eligible participants will be randomly allocated to either (a) treatment group with DN and a self-stretching home program or (b) treatment group with PNE and a self-stretching home program. Each group will receive one treatment session per week over a period of 4 weeks. The primary outcome measure will be the pain subscale of the Foot Health Status Questionnaire. The secondary outcome measures will be a visual analogue scale for pain (average and highest level of pain experienced during the previous 48 h; level of pain immediately after the treatment session) and health-related quality of life (assessed using the EuroQoL-5 dimensions). Cost-effectiveness data will be extracted based on the EuroQoL-5 dimensions. Follow-up measurements will take place at baseline and at 4, 8, 12, 26, and 52 weeks.DiscussionThe justification for this trial is the need to improve current understanding regarding the effectiveness of treatments targeting the rehabilitation of plantar heel pain. This study will be the first randomized controlled trial to directly compare the effectiveness of DN and PNE combined with a specific stretching program for the treatment of plantar heel pain provoked by myofascial trigger points.Trial registrationClinical Trials NCT03236779. Registered at clinicaltrials.gov 2 August 2017.

Project description:BackgroundPlantar heel pain (plantar fasciitis) is a common and disabling condition, which has a detrimental impact on health-related quality of life. Despite the high prevalence of plantar heel pain, the optimal treatment for this disorder remains unclear. Consequently, an alternative therapy such as dry needling is increasingly being used as an adjunctive treatment by health practitioners. Only two trials have investigated the effectiveness of dry needling for plantar heel pain, however both trials were of a low methodological quality. This manuscript describes the design of a randomised controlled trial to evaluate the effectiveness of dry needling for plantar heel pain.MethodsEighty community-dwelling men and woman aged over 18 years with plantar heel pain (who satisfy the inclusion and exclusion criteria) will be recruited. Eligible participants with plantar heel pain will be randomised to receive either one of two interventions, (i) real dry needling or (ii) sham dry needling. The protocol (including needling details and treatment regimen) was formulated by general consensus (using the Delphi research method) using 30 experts worldwide that commonly use dry needling for plantar heel pain. Primary outcome measures will be the pain subscale of the Foot Health Status Questionnaire and "first step" pain as measured on a visual analogue scale. The secondary outcome measures will be health related quality of life (assessed using the Short Form-36 questionnaire - Version Two) and depression, anxiety and stress (assessed using the Depression, Anxiety and Stress Scale - short version). Primary outcome measures will be performed at baseline, 2, 4, 6 and 12 weeks and secondary outcome measures will be performed at baseline, 6 and 12 weeks. Data will be analysed using the intention to treat principle.ConclusionThis study is the first randomised controlled trial to evaluate the effectiveness of dry needling for plantar heel pain. The trial will be reported in accordance with the Consolidated Standards of Reporting Trials and the Standards for Reporting Interventions in Clinical Trials of Acupuncture guidelines. The findings from this trial will provide evidence for the effectiveness of trigger point dry needling for plantar heel pain.Trial registrationAustralian New Zealand 'Clinical Trials Registry'. ACTRN12610000611022.

Project description:ObjectivesTo compare the effectiveness of dry needling (DN) versus percutaneous needle electrolysis (PNE) for improving the level of pain, function and quality of life (QoL) of patients suffering from plantar heel pain (PHP) provoked by myofascial trigger points.DesignA prospective, parallel-group, randomised controlled trial with blinded outcome assessment.SettingA single treatment facility in the State of Kuwait.Participants118 participants were screened for eligibility. Of these, 102 participants were enrolled (30 men (49.5±8.9 years) and 72 women (48.1±8.8 years)) and 68 of them completed the trial.InterventionsTwo parallel groups, one study arm received DN and a stretching protocol whereas the other arm received percutaneous needling electrolysis with a stretching protocol.Primary and secondary outcome measuresThe primary outcome measure was the Foot Pain domain of the Foot Health Status Questionnaire, with 13 questions related to foot health-related domains. Secondary outcome measures included the 0-10 numerical rating scale pain visual analogue scale (VAS) scores, performed before and after each treatment session. In addition, QoL was measured using the EuroQoL-5 dimensions. All measurements were taken at baseline, at 4, 8, 12, 26 and 52 weeks.ResultsFoot Pain domain improved at all time points for DN group (p<0.001; 29.7 (17.8 to 41.5)) and percutaneous needling electrolysis group (p<0.001; 32.7 (18.3 to 47.0)), without significant differences between groups. Pain VAS scores decreased at all time points for both DN (p<0.001; -2.6 (-4.0 to -1.2)) and percutaneous needling electrolysis group (p<0.001; -3.0 (-4.5 to -1.6)). QoL improved at 4 weeks for both DN (p<0.01; 0.15 (0.5 to 0.25)) and percutaneous needling electrolysis group (p<0.01; 0.09 (0.01 to 0.17)) and at 8 and 52 weeks for the PNE group (p<0.01; 0.10 (0.02 to 0.18)), with significant differences between groups for the QoL at 52 weeks (p<0.05; 0.10 (0.01 to 0.18)). There were two small haematomas in the PNE group and one in the DN group. No serious adverse events were reported.ConclusionsBoth PNE and DN were effective for PHP management, reducing mean and maximum pain since the first treatment session, with long lasting effects (52 weeks) and significant differences between groups in the case of QoL at 52 weeks in favour of the PNE group.Trial registration numberNCT03236779.

Dataset Information

Dry needling in addition to standard physical therapy treatment for sub-acromial pain syndrome: a randomized controlled trial protocol.

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Dry needling in addition to standard physical therapy treatment for sub-acromial pain syndrome: a randomized controlled trial protocol.

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