NCT04578366

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2020

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

8 months

First QC Date

September 25, 2020

Last Update Submit

October 6, 2020

Conditions

Adhesive Capsulitis of Shoulder

Outcome Measures

Primary Outcomes (2)

  • 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

    8 months

  • Range of motion

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

    8 months

Secondary Outcomes (1)

  • NPRS-numeric pain rating scale

    8 months

Study Arms (2)

Shockwavetherapy Group/Experimental group

EXPERIMENTAL

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

Device: Extracorporeal Shockwave Therapy

Conventional Group

ACTIVE COMPARATOR

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

Other: Conventional Treatment

Interventions

Extracorporeal Shockwave TherapyDEVICE

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

Also known as: Experimental Group
Shockwavetherapy Group/Experimental group
Conventional TreatmentOTHER

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

Conventional Group

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah IU

Lahore, 54000, Pakistan

Location

Related Publications (7)

  • 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.

    PMID: 16091920BACKGROUND

  • 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.

    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.

    PMID: 12469088BACKGROUND

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

    PMID: 3498494BACKGROUND

  • 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.

    PMID: 29200621BACKGROUND

  • 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.

    PMID: 27899492BACKGROUND

  • 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.

    PMID: 25441567BACKGROUND

MeSH Terms

Conditions

Bursitis

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Maryam Shabbir, M.Phil

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 25, 2020

First Posted

October 8, 2020

Study Start

October 15, 2019

Primary Completion

June 20, 2020

Study Completion

June 28, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)