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临床试验/NCT03442894
NCT03442894已完成不适用

Dry Needling in Addition to Standard Physical Therapy Treatment for Sub-Acromial Pain Syndrome: A Randomized Controlled Trial

59th Medical Wing2 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2018年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
121
试验地点
2
主要终点
Change in Shoulder Pain and Disability Index (SPADI) scores

研究概览

简要总结

This trial will investigate the benefit of trigger point dry needling (DN) for individuals with a common cause of shoulder pain - sub-acromial pain syndrome. Sub-acromial pain syndrome, also knowns as SAPS, is one of the most common causes of shoulder pain. Physical therapy treatments are routinely used for treating SAPS. One treatment approach that has been shown to be beneficial is a combination of exercises and manual or manipulative therapy. This approach has been shown to reduce pain and improve overall shoulder function in individuals with SAPS.

Recently, a novel treatment approach for SAPS has emerged that involves trigger point DN to muscles of the shoulder and ribcage. Some studies have shown promising results for this approach while others have not found it to be helpful. Overall there is currently little research available on the benefit of trigger point DN for individuals with SAPS.

This study will investigate whether adding trigger point DN to a treatment program of exercise and manual therapy provides any benefit to individuals with SAPS. To answer this question, this study will divide subjects into three groups. One group will receive just exercise and manual therapy; one group will receive manual therapy and exercise plus trigger point DN and one group will receive manual therapy and exercise plus a sham trigger point DN treatment.

All patients receiving treatment in the study will attend 10 visits to a physical therapy clinic over a 6-week period. Subjects in the dry needling and sham dry needling groups will receive 6 sessions of this treatment in addition to their 10 sessions of exercise and manual therapy.

The investigators will assess the effectiveness of the three treatment protocols by measuring patients pain, shoulder function and disability levels. These outcomes will be assessed at baseline, six weeks, 6 months and one year from enrolling in the study.

In addition to assessing clinical outcomes following treatment, the investigators will assess the amount of health care utilized by each participant in the year following enrollment in the study. The 3 groups will be analyzed to determine if there is a difference in the amount or type of additional healthcare utilized in the year following study enrollment. Examples of healthcare utilization include x-rays, medication and/or surgical procedures.

The investigators hypothesis is that individuals that receive actual trigger point DN in addition to manual therapy and exercise interventions will demonstrate greater improvements in pain, shoulder function and disability when compared to individuals receiving exercise and manual therapy alone or exercise and manual therapy with sham needling. The investigators think these differences in clinical outcomes will be present at each of the follow-up points. Additionally, the investigators hypothesize that individuals receiving actual DN will use less healthcare than those in the other two groups.

详细描述

STUDY PURPOSE:

The purpose of this study is to assess the long-term additive effectiveness of dry needling (DN) therapy to a standard physical therapy (PT) approach of manual therapy and exercise for patients with subacromial pain syndrome.

HYPOTHESIS AND PRIMARY AIM:

Primary Aim: Compare 1-year outcomes in patients that receive standard PT treatment versus standard PT and DN versus standard PT and sham DN, in patients with SAPS (self-reported outcomes and shoulder-related healthcare utilization). Standard PT will consist of therapeutic exercise and manual therapy, which is considered standard of care PT treatment for individuals with SAPS.

The hypothesis for the primary aim: DN in addition to standard PT treatment will be more effective than standard PT alone. There will be no difference between the Sham DN + standard PT and the standard PT only groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Subjects in the dry needling and sham dry needling groups will be masked (blinded) to whether or not they are receiving the sham or actual dry needling.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 to 65
  • Read and speak English well enough to provide informed consent, follow study instructions, and independently answer the questionnaires/surveys
  • Tricare beneficiary
  • Primary complaint of new episode of shoulder pain; defined as not having sought care for shoulder condition in 6 months prior
  • Available and willing to come in for treatment (~10 sessions over 6 week period)
  • Meets criteria for SAPS from description below, by having 2 of the 4 following physical exam findings:
  • Impingement signs (Neer, Hawkins, or Jobe tests)
  • Painful arc
  • Pain with isometric resistance (ER/IR/ABD)
  • Rotator cuff weakness on the injured side in comparison to the opposite side

排除标准

  • History of shoulder dislocation, subluxation, fracture, adhesive capsulitis of the glenohumeral joint, or cervical/shoulder/upper back surgery
  • Presence of cervical radiculopathy, radiculitis, or referral from cervical spine
  • Total baseline SPADI score less than 20% (to prevent a ceiling effect with treatment)
  • Anyone pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury
  • Unable to give informed consent to participate in the study.
  • Pregnancy

结局指标

主要结局

Change in Shoulder Pain and Disability Index (SPADI) scores

时间窗: Baseline, 6-weeks, 6 months, 12 months

The SPADI is a 100-point, 13 item self-administered questionnaire. It is divided into two subscales: a five item pain subscale and an eight-item disability subscale. Williams et al have shown that the SPADI is responsive to change and accurately discriminates between patients who are improving or worsening. Michener and Leggin also reported a high test-retest reliability and internal consistency for this instrument. When compared to the Sickness Impact Profile (SIP), Heald et al found that the construct validity of the SPADI is moderately strong and it is more responsive to change than the SIP. A recent systematic review identified a minimal detectable change (MDC) of 18 and a minimally clinically important difference (MCID) of between 8-13 points. The validity and responsiveness to change of SPADI have been described in physical therapy, as well as primary and secondary care settings.

次要结局

  • Healthcare Utilization(12 months following enrollment)
  • Patient Reported Outcomes Measurement Information Systems (Promis-29)(Baseline, 6 weeks, 6 months, 12 months)
  • Optimal Screening for Prediction of Referral and Outcome Yellow Flags assessment tool (OSPRO-YF)(Baseline, 6 weeks, 6 months, 12 months)
  • Patient Acceptable Symptom Scale (PASS)(Baseline, 6 weeks, 6 months, 12 months)

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Benjamin Hando

Orthopedic and Rehabilitation Flight Commander

59th Medical Wing

研究点 (2)

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