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

Primary Purpose

Adhesive Capsulitis of Shoulder

Status

Completed

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Extracorporeal Shockwave Therapy

Conventional Treatment

About this trial

This is an interventional treatment trial for Adhesive Capsulitis of Shoulder

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Riphah IU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Shockwavetherapy Group/Experimental group

Conventional Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Constant Shoulder Score (CSS)

The functional outcome of shoulder. Grading the Constant Shoulder Score (Difference between normal and Abnormal Side) >30 Poor 21-30 Fair 11-20 Good <11 Excellent

Range of motion

Oxford Shoulder Score (OSS), increasing score shows improvement, decrease in scores shows deterioration.

Secondary Outcome Measures

NPRS-numeric pain rating scale

This scale ranges 0-10, 10 means severe pain while 0 means no pain

Full Information

NCT ID

NCT04578366

First Posted

September 25, 2020

Last Updated

October 6, 2020

Sponsor

Riphah International University

1. Study Identification

Unique Protocol Identification Number

NCT04578366

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

October 15, 2019 (Actual)

Primary Completion Date

June 20, 2020 (Actual)

Study Completion Date

June 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adhesive Capsulitis of Shoulder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Shockwavetherapy Group/Experimental group

Arm Type

Experimental

Arm Description

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

Arm Title

Conventional Group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Extracorporeal Shockwave Therapy

Other Intervention Name(s)

Experimental Group

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Conventional Treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Constant Shoulder Score (CSS)

Description

The functional outcome of shoulder. Grading the Constant Shoulder Score (Difference between normal and Abnormal Side) >30 Poor 21-30 Fair 11-20 Good <11 Excellent

Time Frame

8 months

Title

Range of motion

Description

Oxford Shoulder Score (OSS), increasing score shows improvement, decrease in scores shows deterioration.

Time Frame

8 months

Secondary Outcome Measure Information:

Title

NPRS-numeric pain rating scale

Description

This scale ranges 0-10, 10 means severe pain while 0 means no pain

Time Frame

8 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maryam Shabbir, M.Phil

Organizational Affiliation

Riphah International University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Riphah IU

City

Lahore

ZIP/Postal Code

54000

Country

Pakistan

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

16091920

Citation

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.

Results Reference

background

Citation

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.

Results Reference

background

PubMed Identifier

12469088

Citation

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.

Results Reference

background

PubMed Identifier

3498494

Citation

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

Results Reference

background

PubMed Identifier

29200621

Citation

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.

Results Reference

background

PubMed Identifier

27899492

Citation

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.

Results Reference

background

PubMed Identifier

25441567

Citation

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.

Results Reference

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

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