NCT06457542

Brief Summary

Shoulder impingement syndrome is primary cause of discomfort and restricted range of motion while reaching above in shoulder region. It is third most common illness affecting musculoskeletal system. The aim of this study will be to analyse comparative effects of active release technique and soft tissue mobilization on pain, range of motion and disability in shoulder impingement syndrome. The study will be a randomized clinical trial. A random sample of 40 subjects with shoulder impingement from Allied hospital, Faisalabad will be evaluated. Subjects who will meet selection criteria will be allocation into two groups by computerized generated allocation method. In addition to ultrasound as baseline treatment group a will receive active release technique while in group B soft tissue mobilization will be administrated for 4 weeks. Treatment session will be 12 session (3 sessions in one week). Baseline, at 2nd week and at 4th week of treatment pain, shoulder elevation, external rotation and shoulder disability will be measure by VAS, goniometer and SPADI. For, data analysis, we will use SPSS software version 23. Data was interrupted through independent t test and repeated measurements ANOVA.

Trial Health

55
Monitor

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 Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

February 17, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

1 month

First QC Date

May 24, 2024

Last Update Submit

June 8, 2024

Conditions

Keywords

Shoulder impingement syndromeActive release techniqueROMSoft tissue mobilizationPain

Outcome Measures

Primary Outcomes (1)

  • Shoulder pain

    Visual Analogue Scale Minimum Value= 0mm Maximum Value= 10mm

    7 minutes

Secondary Outcomes (2)

  • Shoulder range of motion

    10 minutes

  • Shoulder Function

    15 minutes

Study Arms (2)

Active Release Technique

OTHER

Active release technique is a technique used for to treat impingment syndrome.

Other: Active Release Technique

Soft Tissue Mobilization

OTHER

Soft Tissue Moboilization is techniques used for to treat shoulder pain. Soft tissue mobilization (STM) targeting the subscapularis muscle.

Other: Soft Tissue Mobilization

Interventions

Active Release Therapy, which involves instructing the patient to sit and then positioning their shoulder in 90-degree abduction. The therapist will provide assistance to the patient's arm and then examine the supraspinous fossa by applying pressure with a finger. The patient will be instructed to gradually bring the arm towards the body as the therapist manipulates the muscle plane. This procedure should be repeated for a duration of 10 minutes, 3 times per week, over a duration of four weeks.

Active Release Technique

Soft Tissue Mobilization (STM) targeting the subscapularis muscle. The participants will be placed in a position where their upper arm bone (humerus) is raised at a 45° angle, with the elbow bent at a 90° angle. Additionally, the humerus will be rotated outward to a position that is normally around 20° to 25° of external rotation. The subscapularis muscle remained examined by touch in the armpit area to locate regions of limited mobility due to myofascial limitations, trigger points or tense bands. The identified limitations remained addressed with STM, which included applying prolonged manual pressure and slow deep stroke to the subscapularis myofascial. This treatment was performed for a period of 7 minutes, three times a week, over a period of four weeks.

Soft Tissue Mobilization

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age ranges from 40-60 years old
  • Unilateral shoulder involvement
  • A visual analogue scale (VAS) score of 5 or above
  • Abstaining from the use of the painkillers, the anti-inflammatory medicines, and the muscle relaxants for twenty-four hours before to participate
  • The Neer test and the Hawkin's test both yielded favorable results
  • Every participant volunteered their signature on the informed consent form.

You may not qualify if:

  • Open wounds at shoulder
  • Infection at shoulder site or of shoulder joint,
  • Fractures or acute injury
  • Current surgeries
  • Swelling and rheumatoid arthritis,
  • Adhesive capsulitis
  • GH joint instability
  • Acromioclavicular joint-dysfunction;
  • GH joint degenerative joint-disease;
  • Cervical radiculopathy;
  • Receiving steroid injections
  • Receiving of PT intervention for the shoulder discomfort in the previous six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatima Afzaal

Faisalābad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Conditions

Shoulder Impingement SyndromePain

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Model involves two groups having disease of shoulder impigement syndrome. First group recieves treatment active release technique and Second group recieves soft tissue mobilization.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 24, 2024

First Posted

June 13, 2024

Study Start

February 17, 2024

Primary Completion

March 29, 2024

Study Completion

June 1, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations