NCT07410208

Brief Summary

Background Shoulder impingement syndrome is the most common disorder of the shoulder. Study results on the effectiveness of treatment options are inconclusive and limited. Therefore, more evidence is needed for long-term results Objective To investigate the effectiveness of the ideal physiotherapy protocol (IPRP-PT) applied after platelet-rich plasma (PRP) injection on pain and functionality in patients with shoulder impingement syndrome, and to propose an alternative treatment protocol. Methods The study was performed in 54 patients with shoulder impingement syndrome who were injected with PRP. Patients were randomly divided into two equal groups. For 21 days, the study group received IPRP-PT study protocol, conventional physiotherapy and home exercise programme, while the control group received only conventional physiotherapy programme. Normal range of motion, muscle strength and posture were assessed. In addition, short form Mc-gill (SF-MPQ), Visual Analogue Scale (VAS), Constant Murley Shoulder Score, Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH), Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA), were used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

January 21, 2026

Last Update Submit

April 9, 2026

Conditions

Keywords

Shoulder Impingement SyndromePlatelet-Rich PlasmaExercisePainFunctionality

Outcome Measures

Primary Outcomes (3)

  • Posture Assessment

    Corbin posture scale was used. Postural scores obtained by looking laterally and posteriorly were summed and evaluated as (0-2: excellent, 3-4: very good, 5-7: good, 8-11: fair, 12≥ poor).

    Baseline and Day 21

  • Range of Motion (ROM) Evaluation

    Normal joint movements were assessed using a universal goniometer. Passive and active shoulder joint flexion, extension, abduction, internal rotation, and external rotation were evaluated.

    Baseline and Day 21

  • Manual Muscle Test

    During the manual muscle test, the patient was positioned appropriately for the muscle being evaluated. They were asked to actively perform the movement. The force generated by the muscle was evaluated by applying manual resistance. Muscle strength of the shoulder flexors, extensors, abductors, internal rotators, and external rotators was rated on a scale of 0-5 (no contraction 0, very weak 1, weak 2, moderate 3, good 4, and normal 5.

    Baseline and Day 21

Secondary Outcomes (4)

  • Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)

    Baseline and Day 21

  • Constant Murley Shoulder Score (CMS)

    Baseline and Day 21

  • Pain Assessment

    Baseline and Day 21

  • Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA)

    Baseline and Day 21

Study Arms (2)

Study group

EXPERIMENTAL
Drug: Platelet Rich Plasma (PRP)Other: Conventional physiotherapy programmeOther: IPRP-PT Study Protocol

Control Group

ACTIVE COMPARATOR
Drug: Platelet Rich Plasma (PRP)Other: Conventional physiotherapy programme

Interventions

It was applied once a day for 21 days to 54 patients included in the study. Ultrasound; Enraf Nonius Sonopuls692V® device was applied around the glenohumeral joint with an average treatment dose of 3 MHz, N 1.5 w/cm² and 8 minutes. Transcutaneous Electrical Nerve Stimulation (TENS); Enraf Nonius Sonopuls 692V® device was applied to the glenohumeral joint with a frequency between 60-120 Hz and a transition time of 50-100 µsec for 20 min. Hot Pack; It was applied to the glenohumeral joint for 20 minutes (Kuhn, 2009; Kul and Ugur, 2019; Walsh, Howe, Johnson, and Sluka, 2009).

Control GroupStudy group

All patients included in the study were educated about the correct posture in daily life, sleeping position, and the things to be followed to improve the quality of life. In addition to 2 cc anticoagulant citrate dextrose withdrawn syringe, 20 cc of blood was taken by the nurse from the patients diagnosed with shoulder impingement syndrome. After the blood was transferred to a special PRP kit and centrifuged at 4000 rpm for 8-9 minutes, the platelet-rich plasma portion remaining at the top of the kit was taken into the syringe and applied to the 1/3 posterolateral 1/3 of the glenohumeral joint by the physician. After PRP injections, evaluations of the study and control groups were performed before and after 21 days of treatment. The study group received IPRP-PT study protocol, conventional physiotherapy and home exercises, while the control group received only conventional physiotherapy and home programme.

Control GroupStudy group

IPRP-PT study protocol was applied in addition to conventional physiotherapy for 21 days in 27 patients who underwent PRP injection in our study group. The exercises were performed once a day with a physiotherapist and twice a day at home. The exercises performed were as follows; posterior capsule stretching; wand exercise; scapulatoracic (st), acromioclavicular (ac) and sternoclavicular (sc) joint mobilisation; GH joint posterior, anterior, inferior sliding; GH joint distraction; deep friction massage of the tendon of the supraspinatus muscle; kinesiological taping; isometric and isotonic strengthening exercises; proprioceptive neuromuscular facilitation exercises (pnf); closed kinetic ring and proprioception exercises

Study group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 30-65 years
  • Diagnosis of stage I or II shoulder impingement syndrome
  • Received one dose of PRP injection
  • Referred for and seeking physical therapy
  • Voluntary participation
  • Ability to cooperate with the study procedures

You may not qualify if:

  • Previous surgical treatment for shoulder impingement syndrome
  • Presence of other orthopedic conditions (e.g., shoulder fractures)
  • Presence of neuromuscular disease
  • Presence of a pacemaker
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstinye Üniversitesi

Istanbul, Merkez, 08100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement SyndromeMotor ActivityPain

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 21, 2026

First Posted

February 13, 2026

Study Start

July 15, 2019

Primary Completion

March 20, 2020

Study Completion

July 30, 2020

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Plan Description: Individual participant data will not be shared. Access Criteria: Data sharing is not planned due to ethical and confidentiality considerations.

Locations