NCT07601568

Brief Summary

To investigate the effect of PMI release on subacromial space, pectoralis minor length, shoulders ROM, shoulder joint pain, and functional ability in patients with SAIS.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started May 2026

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 Progress5%
May 2026Jan 2027

First Submitted

Initial submission to the registry

May 10, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

May 11, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2027

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

May 10, 2026

Last Update Submit

May 15, 2026

Conditions

Keywords

Shoulder JointSubacromial SpacePectoralis Minor

Outcome Measures

Primary Outcomes (1)

  • Subacromial space will be measured by X-ray image

    The radiograph will be done to measure acromio-humeral distance, which is considered the shortest distance between the inferior cortex of acromion and the top of humeral head. In normal shoulders, the sub acromial space was between 9 and 10 mm. The space was significantly greater in men, with a slight reduction with age. In middle age, a sub-acromial space less than 6 mm is pathological

    6 months

Secondary Outcomes (4)

  • Pectoralis minor length will be measured by tape measurement

    6 month

  • Shoulder joint ROM (flexion, abduction, internal and external rotation) will be measured by inclinometer

    6 month

  • Pain intensity will be measured by using VAS ( visual analog scale)

    6 month

  • Identification of Functional Ability of the shoulder joint using Q-DASH questionnaire with Arabic version

    6 month

Study Arms (2)

traditional group

SHAM COMPARATOR

Thirty patients will receive traditional physical therapy treatment (Postural correction exercises and scapular stabilization exercises) at the painful shoulder, Treatment sessions will be two times per week for six weeks

Other: conventional physical therapy

Experimental Group

EXPERIMENTAL

Thirty patients will receive traditional treatment plus pectoralis minor stretching and release, Treatment sessions will be two times per week for six weeks.

Other: conventional physical therapyOther: Experimental group therapy

Interventions

Physiotherapy treatment included passive manual joint mobilization, home-based strengthening exercises and advice on posture, twice a week. So, we will apply this conventional physical therapy to control group 1. Postural correction exercise * Patient can apply this exercise on prone lie position for against a wall as in figure 10. * patient will start with chin in exercise, will asked to pull his chine in and push the wall, then hold for 15 seconds and repeat for 3 times. * Patient will try to touch both shoulders to the wall and hold for 15 seconds. * Patient will be asked to straight all spine against the wall and hold for 15 seconds. 2. Scapular stabilization exercise Patient will lie prone with elbow extended, start to move his arm away from his body (horizontal abduction), with wait or without according to Lafayette muscle test results. Apply 2 cycle and each cycle will have 10 times repetitions

Experimental Grouptraditional group

Treatment will be conventional treatment with pectoralis minor release and stretch. * Pectoralis minor stretch The subject lying in a supine position with a towel roll running the length of the thoracic spine. The subject's shoulder at 90° of abduction and external rotation and the elbow at 90° flexion while therapist applying a posterior force to the coracoid process, in this study stretch will be performed for two sequential repetitions, holding the stretches for 30 seconds with 30 second break * Pectoralis minor release the subject in a supine position with the test arm at his side while the therapist palpated medially into the proximal axilla, followed by proceeding superiorly towards the coracoid process then applied pressure in the anterior direction, similar to attempting to lift the muscle, therapist applying tensile force directly to the pectoralis minor. The opposite therapist hand will stabilize the scapula and humeral head maintain for 30 seconds and repeat 2 times

Experimental Group

Eligibility Criteria

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

You may qualify if:

  • Patients with chronic unilateral SAIS.
  • Patient age average 40- 60 years old from both sexes (Michael and Gail 2000).
  • Decreased AHD less than 10mm by x-ray image (Mean AHD in absence of rotator cuff tear is 10.5mm (Goutallier et al., 2011)).
  • Decreased of active shoulder ROM.
  • Presence of unilateral shoulder joint pain.
  • Reliable patients.

You may not qualify if:

  • All patients who have any of the following will be excluded from the study (Lewis and Valentine 2007)
  • Intra articular injection.
  • Arthroscopic intervention.
  • Previous shoulder fracture.
  • Shoulder subluxation.
  • Adhesive capsulitis.
  • Shoulder osteoarthritis.
  • Any previous operation on cervical and shoulder region.
  • Mastectomy on the same side of shoulder impingement.
  • Patients with neurological disorder that may contribute performance the procedure instructions.
  • Osteoporosis.
  • Pregnant and lactating woman.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Cairo University

Giza, Dokki, 12612, Egypt

Location

Related Publications (1)

  • Abu EL Kasem Sh., Alaa F., Abd EL-Raoof N. et al., (2024):" Efficacy of Mulligan thoracic sustained natural apophyseal glides on sub-acromial pain in patients with sub-acromial impingement syndrome: a single-blinded randomized controlled trial "journal of manual & manipulative therapy 10.1080/10669817.2024.2341453 Amado A., Marques A., Maiorino R. et al., (2006):" An Anatomical Study of The Subcoracoid Space" CLINICS 2006;61(5):467-72 Ann Sisto S. and Dyson-Hudson T. (2007):" Dynamometry testing in spinal cord injury" Journal of Rehabilitation Research & Development, Volume 44, Number 1 Anne T., Herrington L., Horlsey I. et al. (2015):" An evidence-based review of current perceptions with regard to the subacromial space in shoulder impingement syndromes: Is it important and what influences it?" Clinical Biomechanics , Volume 30, Issue 7, August 2015, Pages 641-648

    BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physical Therapist

Study Record Dates

First Submitted

May 10, 2026

First Posted

May 22, 2026

Study Start

May 11, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 12, 2027

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations