Extracorporeal Shockwave Therapy in Long-term Functional Outcomes of Shoulder Adhesive Capsulitis

NCT ID: NCT04578366

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2020-06-28

Brief Summary

Adhesive capsulitis refers to the occurrence of pain and a gradual decline in the range of motion (ROM) due to slow increases in synovial hypertrophy and the adhesion between the synovial membrane and articular surface. It leads to the loss of flexibility and difficulties with the activities of daily living (ADLs) due to chronic inflammation accompanied by intra-articular fibrosis. The real cause of this syndrome is unknown but there are some predisposing factors involved such as synovial cell hyperplasia, fibrosis of the capsule due to cytokines or other inflammatory factors. In the current study investigator will compare the effects of Extracorporeal Shockwave Therapy (ESWT) along with conventional therapy to treat the adhesive capsulitis.

Detailed Description

This study will be a Randomized Controlled Trail conducted at Horizon hospital, Lahore. The study will be completed within the time duration of Six months. Consecutive sampling technique will be used to collect the data. The sample size of 44 patients will be taken in this study to find the effects of ESWT on pain, ROM, functional mobility. Patient will be divided into two groups. Group A will be treated with ESWT with conventional therapy and Group B will be treated with conventional therapy. Constant Shoulder Score (CSS) and the Oxford Shoulder Score (OSS) tools will be used to measure the outcomes of the study.

One session of treatment per week for four weeks will be given. Pretest, posttest at 4th week and followup of 24th weeks will be evaluated.

Conditions

Adhesive Capsulitis of Shoulder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Shockwavetherapy Group/Experimental group

ESWT along with conventional therapy ESWT + hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder

Group Type: EXPERIMENTAL

Extracorporeal Shockwave Therapy

Intervention Type: DEVICE

ESWT along with conventional therapy ESWT + hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder

Conventional Group

Conventional therapy hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder

Group Type: ACTIVE_COMPARATOR

Conventional Treatment

Intervention Type: OTHER

hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder

Interventions

Extracorporeal Shockwave Therapy

ESWT along with conventional therapy ESWT + hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder

Intervention Type: DEVICE

Conventional Treatment

hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder

Intervention Type: OTHER

Other Intervention Names

Experimental Group

Eligibility Criteria

Inclusion Criteria

• Relapsed or episode of pain score ≥5 at assessment with a past history of pain for at least 2 months.
• ROM restriction (>75% ROM loss in ≥2 directions including abduction, flexion and external rotation)
• No treatment other than analgesics with unresponsive ROM restriction for the past 2months.
• Unwilling or waiting and did not undergo joint injection.

Exclusion Criteria

• bilateral shoulder involvement
• History of previous surgery on the shoulder
• Shoulder fracture
• Cancer
• Glenohumeral or Acromioclavicular arthritis
• Inflammatory disorders
• Bleeding disorders
• Diabetes mellitus
• Presence of severe osteoporosis
• Pulmonary diseases
• Any neuromuscular disorders
• Pregnancy
• Implanted pacemaker

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maryam Shabbir, M.Phil

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Riphah IU

Lahore, , Pakistan

Countries

Pakistan

References

Calis M, Demir H, Ulker S, Kirnap M, Duygulu F, Calis HT. Is intraarticular sodium hyaluronate injection an alternative treatment in patients with adhesive capsulitis? Rheumatol Int. 2006 Apr;26(6):536-40. doi: 10.1007/s00296-005-0022-2. Epub 2005 Aug 10.

Reference Type: BACKGROUND

PMID: 16091920 (View on PubMed)

Hussein AZ, Donatelli RA. The efficacy of radial extracorporeal shockwave therapy in shoulder adhesive capsulitis: a prospective, randomised, double-blind, placebo-controlled, clinical study. European Journal of Physiotherapy. 2015;18(1):63-76.

Reference Type: BACKGROUND

Massoud SN, Pearse EO, Levy O, Copeland SA. Operative management of the frozen shoulder in patients with diabetes. J Shoulder Elbow Surg. 2002 Nov-Dec;11(6):609-13. doi: 10.1067/mse.2002.127301.

Reference Type: BACKGROUND

PMID: 12469088 (View on PubMed)

Wohlgethan JR. Frozen shoulder in hyperthyroidism. Arthritis Rheum. 1987 Aug;30(8):936-9. doi: 10.1002/art.1780300815.

Reference Type: BACKGROUND

PMID: 3498494 (View on PubMed)

Lee S, Lee S, Jeong M, Oh H, Lee K. The effects of extracorporeal shock wave therapy on pain and range of motion in patients with adhesive capsulitis. J Phys Ther Sci. 2017 Nov;29(11):1907-1909. doi: 10.1589/jpts.29.1907. Epub 2017 Nov 24.

Reference Type: BACKGROUND

PMID: 29200621 (View on PubMed)

Santoboni F, Balducci S, D'Errico V, Haxhi J, Vetrano M, Piccinini G, Ferretti A, Pugliese G, Vulpiani MC. Extracorporeal Shockwave Therapy Improves Functional Outcomes of Adhesive Capsulitis of the Shoulder in Patients With Diabetes. Diabetes Care. 2017 Feb;40(2):e12-e13. doi: 10.2337/dc16-2063. Epub 2016 Nov 29. No abstract available.

Reference Type: BACKGROUND

PMID: 27899492 (View on PubMed)

Chen CY, Hu CC, Weng PW, Huang YM, Chiang CJ, Chen CH, Tsuang YH, Yang RS, Sun JS, Cheng CK. Extracorporeal shockwave therapy improves short-term functional outcomes of shoulder adhesive capsulitis. J Shoulder Elbow Surg. 2014 Dec;23(12):1843-1851. doi: 10.1016/j.jse.2014.08.010.

Reference Type: BACKGROUND

PMID: 25441567 (View on PubMed)

Other Identifiers

RE-MS-OMPT/Spring19/032 Adnan

Identifier Type: -

Identifier Source: org_study_id