Dry Needling and Exercise Versus Traditional Physical Therapy for Biceps Tendinitis

NCT04073212 | Withdrawn

• 1 other identifier: 19-2791
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Bicep Tendinitis; Biceps; Tenosynovitis; Bicipital Tendinitis, Left Shoulder; Bicipital Tendinitis, Right Shoulder; Bicipital Tendinitis, Unspecified Shoulder; Biceps Tendon Disorder

Keywords

dry needling; eccentric exercise; concentric exercise; physical therapy; heavy slow load exercise

Outcome Measures

Primary Outcomes (4)

• American Shoulder and Elbow Surgeons Scale (ASES) at 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.

  Baseline

• American Shoulder and Elbow Surgeons Scale (ASES) at 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.

  3 weeks

• American Shoulder and Elbow Surgeons Scale (ASES) at 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.

  12 weeks

• American Shoulder and Elbow Surgeons Scale (ASES) at 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.

  6 months

Secondary Outcomes (23)

• Numeric Pain Rating Scale (NPRS) at Baseline

  Baseline

• Numeric Pain Rating Scale (NPRS) 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 Baseline

  Baseline

Study Arms (2)

Intervention 1 DN+HSLE

EXPERIMENTAL

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.

Other: Dry Needling; Other: Heavy Slow Load Exercise; Other: Rotator cuff and scapular stabilization exercise program; Other: Soft tissue mobilization

Intervention 2 Control

ACTIVE COMPARATOR

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.

Other: Rotator cuff and scapular stabilization exercise program; Other: Soft tissue mobilization

Interventions

Dry Needling OTHER

Dry needling directly to the long head of the biceps tendon. The DN will be performed with disposable stainless-steel needles (.3 X 40mm; Seirin; Weymouth, MA) inserted into the skin over the most painful and/or thickened areas of the tendon, confirmed with palpation. Prior to insertion of the needle the overlying skin will be cleaned with alcohol. The needle will be inserted into the tendon. The technique will be a fast-in and fast-out technique described by Chiavaras et al.26 for 20-30 repetitions per session in up to 3 areas. An eccentric-concentric exercise program of the biceps muscle/tendon will follow each DN session and will be performed daily for the course of treatment and will be performed as described by McDevitt et al.

Also known as: Manual Therapy

Intervention 1 DN+HSLE

Heavy Slow Load Exercise OTHER

Eccentric exercise protocols have been found to be an effective treatment for tendinopathies of the upper and lower extremities and recent evidence supports heavy slow resistance training (including the addition of a concentric phase) as having better outcomes over eccentric exercise alone. Patients will use 1-5 pound weights to perform slow and controlled concentric and eccentric exercise to biceps muscle.

Also known as: Therapeutic Exercise

Intervention 1 DN+HSLE

Rotator cuff and scapular stabilization exercise program OTHER

Both groups will be treated with a stretching and strengthening program. The rotator cuff and scapular stabilization strengthening and flexibility program used in this study has 3 phases and patients progress in phases based on their ability to perform a number of exercises using theraband or body weight resistance.

Also known as: Therapeutic Exercise

Intervention 1 DN+HSLE; Intervention 2 Control

Soft tissue mobilization OTHER

Both groups will receive soft tissue mobilization to the anterior shoulder.

Also known as: Manual Therapy

Intervention 1 DN+HSLE; Intervention 2 Control

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of Newcastle, Australia: collaborator

Study Sites (2)

Education 1 Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Boulder Center for Sports Medicine and Performance

Boulder, Colorado, 80309, United States

Location

MeSH Terms

Conditions

Tenosynovitis

Interventions

Dry Needling; Musculoskeletal Manipulations; Exercise Therapy

Condition Hierarchy (Ancestors)

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Amy W McDevitt, DPT

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Concealed allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with 2 arms or treatment groups

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 29, 2019
• Study Start: September 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)