Dry Needling and Heavy Slow Load Exercise Versus Traditional Physical Therapy in the Treatment of Individuals With Bicipital Tendinopathy; A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 2
- Primary Endpoint
- American Shoulder and Elbow Surgeons Scale (ASES) at 3 Weeks
Study Overview
Brief Summary
The aim of the research is to determine if participants who receive physical therapy (physiotherapy) including soft tissue mobilization, dry needling, Heavy slow load (eccentric-concentric) exercise (with hand weights specific to the biceps muscle) and a comprehensive rotator cuff and scapular stabilization program achieve greater reductions in pain and disability in the short (3-4 weeks) and long term (6 months) compared to those who receive soft tissue mobilization and a comprehensive rotator cuff and scapular stabilization program. Both treatment approaches are within the standard of care for physical therapists, the aim being to determine the most effective treatment approach. Study participants will be recruited form clinicians and flyers within the university/hospital organization where the study is taking place. Participants will be asked to attend 6 physical therapy visits and complete 6 surveys about their pain and disability.
Detailed Description
The overall purpose of the pilot study is to test the feasibility of methods and procedures for later use to conduct a large study to determine if patients who receive physical therapy including dry needling, heavy slow load exercise and a comprehensive rotator cuff and scapular stabilization program achieve greater reductions in pain and disability in the short (4 weeks) and long term (6 months) compared to those who receive soft tissue mobilization and a comprehensive rotator cuff and scapular stabilization program. A secondary purpose is to search for possible effects and associations between variables that may be worth following up in a subsequent, larger study.
Hypothesis: 1) Individuals with biceps tendinopathy who receive an intervention of soft tissue mobilization, dry needling (DN), heavy slow load exercise (HSLE) and a comprehensive rotator cuff and scapular stabilization program will demonstrate significant differences in disability and pain scores compared to the control group as measured by the:
- American Shoulder and Elbow Surgeons Standardized Shoulder Form (ASES.) This improvement will be a minimum mean difference of 8 points (standard deviation, 12 points) between groups which would indicate a clinically meaningful improvement.
- Disabilities of the Arm Shoulder and Hand (DASH)
- Patient Specific Functional Scale (PSFS)
- Numeric Pain Rating Score (NPRS)
- Shoulder Hand and Disability Index (SPADI)
Inclusion Criteria:
- Age 18-64 years old
- Primary complaint of anterior shoulder pain in the area of the LHBT
- Clinical exam findings (must have positive findings for at least 1/2 of the following). Several tests have been described for isolating pathology of the LHBT, however literature has shown that none of these tests are specific enough in isolation to confirm the diagnosis9 and Speed's test and Yergason's test do not perform consistently and they do not generate a large change in post-test probability.59 Additionally, better diagnostic utility is accomplished when 2 highly sensitive tests and one highly specific test60 however, Speed's and Yergason's tests are both specific. Therefore, it was decided that 1/2 specific tests would still be potentially inclusive of the pathology since neither of the tests is specific enough to confirm diagnosis either combined or in isolation.9,61 A test cluster of Speed's test combined with biceps palpation was reported to have a sensitivity of 68% and a specificity of 49%.12
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Concealed allocation
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-64 years old
- •Primary diagnosis of bicipital tendinopathy
- •Primary complaint of anterior shoulder pain in the area of the LHBT
- •Clinical exam findings (must have positive findings for at least 1/2 of the following: Speed's Test, Yergason's test for biceps tendon pain.
- •Pain with palpation in area of the biceps tendon
- •Patient identification of pain in the area of the proximal biceps tendon
- •NPRS of at least 3/10 at worst in the past week
Exclusion Criteria
- •History of biceps tendon injection in the past 3 months
- •History of rotator cuff surgery
- •History of biceps tenodesis or tenotomy
- •History of bleeding disorder or anti-coagulation therapy
- •Diagnosis of adhesive capsulitis (as defined by 50% loss of range of motion in 2 out of 3 of the following motions: Shoulder flexion, abduction and external rotation)
- •Known underlying non-modifiable medical condition (e.g. tumor, fracture, metabolic disease)
- •Two or more positive neurological signs consistent with nerve root compression
- •Known allergy to metal
- •Participant reported aversion to needles
Arms & Interventions
Intervention 1 DN+HSLE
Patients in the intervention 1 Dry Needling (DN)+heavy Slow Load Exercise (HSLE) group will attend physical therapy one to two sessions per week for up to 4 weeks for a total of 6 sessions. Each treatment session will last for a total of 45 minutes. A standardized physical therapy program will be used and will include soft tissue mobilization to the shoulder and biceps tendon followed by DN, HSLE and a standardized shoulder strengthening exercise program.
Intervention: Dry Needling (Other)
Intervention 1 DN+HSLE
Patients in the intervention 1 Dry Needling (DN)+heavy Slow Load Exercise (HSLE) group will attend physical therapy one to two sessions per week for up to 4 weeks for a total of 6 sessions. Each treatment session will last for a total of 45 minutes. A standardized physical therapy program will be used and will include soft tissue mobilization to the shoulder and biceps tendon followed by DN, HSLE and a standardized shoulder strengthening exercise program.
Intervention: Heavy Slow Load Exercise (Other)
Intervention 1 DN+HSLE
Patients in the intervention 1 Dry Needling (DN)+heavy Slow Load Exercise (HSLE) group will attend physical therapy one to two sessions per week for up to 4 weeks for a total of 6 sessions. Each treatment session will last for a total of 45 minutes. A standardized physical therapy program will be used and will include soft tissue mobilization to the shoulder and biceps tendon followed by DN, HSLE and a standardized shoulder strengthening exercise program.
Intervention: Rotator cuff and scapular stabilization exercise program (Other)
Intervention 1 DN+HSLE
Patients in the intervention 1 Dry Needling (DN)+heavy Slow Load Exercise (HSLE) group will attend physical therapy one to two sessions per week for up to 4 weeks for a total of 6 sessions. Each treatment session will last for a total of 45 minutes. A standardized physical therapy program will be used and will include soft tissue mobilization to the shoulder and biceps tendon followed by DN, HSLE and a standardized shoulder strengthening exercise program.
Intervention: Soft tissue mobilization (Other)
Intervention 2 Control
Patients in the control group will attend physical therapy one to two sessions per week for up to 4 weeks for a total of 6 sessions. Each treatment session will last for a total of 45 minutes. A standardized physical therapy program will be used and will include soft tissue mobilization to the shoulder and biceps tendon and a standardized exercise program. Dry needling nor heavy slow load exercise will not be integrated into the "control" plan of care.
Intervention: Rotator cuff and scapular stabilization exercise program (Other)
Intervention 2 Control
Patients in the control group will attend physical therapy one to two sessions per week for up to 4 weeks for a total of 6 sessions. Each treatment session will last for a total of 45 minutes. A standardized physical therapy program will be used and will include soft tissue mobilization to the shoulder and biceps tendon and a standardized exercise program. Dry needling nor heavy slow load exercise will not be integrated into the "control" plan of care.
Intervention: Soft tissue mobilization (Other)
Outcomes
Primary Outcomes
American Shoulder and Elbow Surgeons Scale (ASES) at 3 Weeks
Time Frame: 3 weeks
shoulder pain and disability; The ASES is a 100-point shoulder-specific self-report questionnaire consisting of 2 subscales including pain and disability. Lower scores are indicative of higher levels of disability.
American Shoulder and Elbow Surgeons Scale (ASES) at 12 Weeks
Time Frame: 12 weeks
shoulder pain and disability; The ASES is a 100-point shoulder-specific self-report questionnaire consisting of 2 subscales including pain and disability. Lower scores are indicative of higher levels of disability.
American Shoulder and Elbow Surgeons Scale (ASES) at Baseline
Time Frame: Baseline
shoulder pain and disability; The ASES is a 100-point shoulder-specific self-report questionnaire consisting of 2 subscales including pain and disability. Lower scores are indicative of higher levels of disability.
American Shoulder and Elbow Surgeons Scale (ASES) at 6 Months
Time Frame: 6 months
shoulder pain and disability; The ASES is a 100-point shoulder-specific self-report questionnaire consisting of 2 subscales including pain and disability. Lower scores are indicative of higher levels of disability.
Secondary Outcomes
- Numeric Pain Rating Scale (NPRS) at Baseline(Baseline)
- Numeric Pain Rating Scale (NPRS) at 3 Weeks(3 weeks)
- DASH score at Baseline(Baseline)
- Global Rating of Change (GROC) at 3 Weeks(3 weeks)
- Numeric Pain Rating Scale (NPRS) at 12 Weeks(12 weeks)
- Numeric Pain Rating Scale (NPRS) at 6 Months(6 months)
- DASH score at 3 Weeks(3 weeks)
- DASH score at 6 Months(6 months)
- Should Pain and Disability Index(6 months)
- Patient specific functional scale (PSFS) at 12 Weeks(12 weeks)
- Global Rating of Change (GROC) at 6 Months(6 months)
- Medication Usage at 12 Weeks(12 weeks)
- Medication Usage at 6 Months(6 months)
- DASH score at 12 Weeks(12 weeks)
- Patient specific functional scale (PSFS) at Baseline(Baseline)
- Patient specific functional scale (PSFS) at 3 Weeks(3 weeks)
- Patient specific functional scale (PSFS) at 6 Months(6 months)
- Global Rating of Change (GROC) at 12 Weeks(12 weeks)
- Medication Usage at Baseline(baseline)
- Medication Usage at 3 Weeks(3 weeks)
- Should Pain and Disability Index(Baseline)
- Should Pain and Disability Index(3 weeks)
- Should Pain and Disability Index(12 weeks)