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

October 6, 2020 updated by: Riphah International University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Lahore, Pakistan, 54000
        • Riphah IU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Shockwavetherapy Group/Experimental group
ESWT along with conventional therapy ESWT + hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder
Device: Extracorporeal Shockwave Therapy
ESWT along with conventional therapy ESWT + hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder
Other Names:
  • Experimental Group
ACTIVE_COMPARATOR: Conventional Group
Conventional therapy hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder
Other: Conventional Treatment
hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constant Shoulder Score (CSS)
Time Frame: 8 months

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
Time Frame: 8 months
Oxford Shoulder Score (OSS), increasing score shows improvement, decrease in scores shows deterioration.
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NPRS-numeric pain rating scale
Time Frame: 8 months
This scale ranges 0-10, 10 means severe pain while 0 means no pain
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Maryam Shabbir, M.Phil, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 15, 2019

Primary Completion (ACTUAL)

June 20, 2020

Study Completion (ACTUAL)

June 28, 2020

Study Registration Dates

First Submitted

September 25, 2020

First Submitted That Met QC Criteria

October 6, 2020

First Posted (ACTUAL)

October 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RE-MS-OMPT/Spring19/032 Adnan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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