NCT06079944

Brief Summary

A randomized control trial will be done on diagnosed Shoulder impingemnet patients with physical therapy screening in Fauji Foundation Hospital Rawalpindi. There is a growing demand on finding treatments which can be more beneficial and can be started early on in the treatment phase, nowadays. The purpose of the study is to determine the "effects of progressive resistance training combined with traditional physical therapy in patients with shoulder impingement syndrome" using the resistance band and multipulley system. The traditional physical therapy will include hot pack placed on shoulder and neck region for ten minutes, Transcutaneous electrical nerve stimular will be used and the electrodes will be placed on the desired area (shoulder complex) the intensity will be increased manually according to the capacity of the patient and the treatment time will be of 15 minutes, stretching exercises such as doorway stretch and foam roll supine stretch will be done in the hospital for first 3 weeks and the next 3 weeks will be for home exercises moving from 5 repetitions to 20 repetitions for a set of 3. stretch will be hold for 30 seconds

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 8, 2023

Last Update Submit

October 8, 2023

Conditions

Keywords

Exercises, Impingement syndrome, Physical therapy , Resistance training, Shoulder pain

Outcome Measures

Primary Outcomes (2)

  • Pain intensity using Numeric pain rating scale (NPRS)

    change in the values of pain using Numeric pain rating scale from the base line then week 3 and then to the end of 6 weeks

    6 weeks

  • Shoulder range of motion using Goniometer

    Shoulder range of motion will be assessed using goniometer in flexion, extension, abduction, external and internal rotation of shoulder for both the study and control group

    6 weeks

Study Arms (2)

Group A- Control group

ACTIVE COMPARATOR

Group (A)/ control group Involves participants receiving 1. TENS+ hot pack (10mins) 2. Pendulum exercises and stretching exercises This group will not receive resistance training from 5 repetitions to 20 repetitions of door way stretch (maintained for 30seconds), pendulum exercises and foam roll strtech will be provided over the 6 weeks protocol

Procedure: Traditional physical therapy

Group B- Study Group

EXPERIMENTAL

Group (B)/ Experimental group involves participants receiving Traditional l physical therapy for shoulder impingement syndrome for 6 weeks. 1. TENS+ hot pack (10mins) 2. Pendulum exercises and stretching exercises 3-6RM Load will be determined after which multipulley system will be used for treatment and treatment will be divided in to two series of 8 repetition: 25%, 30%,35%,40%, 50% of 6RM over the period of 6 weeks Speed of movement will be 2 seconds for both the eccentric and concentric phases. To strengthen the shoulder muscles patients will perform flexion, extension, medial and lateral rotation It is a combined treatment so study group will receive both study group and control group intervention

Procedure: Progressive resistance trainingProcedure: Traditional physical therapy

Interventions

* 6RM Load will be determined after which multipulley system will be used for treatment and treatment will be divided in to two series of 8 repetition: * 25%, 30%,35%,40%, 50% of 6RM over the period of 6 weeks * Speed of movement will be 2 seconds for both the eccentric and concentric phases. * To strengthen the shoulder muscles patients will perform flexion, extension, medial and lateral rotation using multipulley system.

Group B- Study Group

* TENS+ Hot pack * Pendulum exercises and stretching exercises

Group A- Control groupGroup B- Study Group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both genders.(Male and Female)
  • Young early adulthood with age 20-40 years.
  • Diagnosed cases of Shoulder impingement syndrome.

You may not qualify if:

  • Active joint disease (rheumatoid, or any other rheumatological diseases
  • Any history of Cardiovascular events
  • Any history of upper limb surgery
  • Hematological disease.
  • Osteoporosis.
  • osteomyelitis
  • Active fractures/ non or mal-union fractures
  • Rotator cuff tears
  • Adhesive capsulitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Shoulder Impingement SyndromeMotor ActivityShoulder Pain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesBehaviorArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Esma Araf, MSKPT

CONTACT

Study Design

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

Study Record Dates

First Submitted

October 8, 2023

First Posted

October 12, 2023

Study Start

March 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 30, 2024

Last Updated

October 12, 2023

Record last verified: 2023-10

Locations