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CompletedNCT03958227Updated Jan 2, 2020

Investigation The Efficacy of Manual Therapy and Exercise in Patients With Glenohumeral Arthritis

An interventional study of Manuel Therapy plus Exercise Intervention and Exercise Intervention in Glenohumeral Arthritis, sponsored by Istanbul University. Completed at 1 site in Turkey. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2020-01-02.

Sponsored by Istanbul University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

The aim of the investigator's study is to compare the efficacy of manual therapy and exercise practices compared to exercise practice in patients with Glenohumeral Arthritis. Thirty volunteer patients will include into the study.

Read the detailed description

Patients will randomly divide into two groups. A common exercise program was applied to both groups during 15 sessions. Manual therapy techniques will apply to the manual therapy group in addition to exercise practices. Patients will evaluate in terms of functional status, pain, range of motion, muscle strength and health-related quality before and after 5 weeks of treatment. Also, patient's satisfaction from treatment will evaluate at the 5th week of the treatment. DASH and ASES forms for functional status, VAS for pain, digital goniometer for range of motion, manual muscle test for muscle strength, SF-12 for health-related quality of life, and Global Rating of Change (GRC) Scale for patient satisfaction will be used as evaluation criteria.

02

Conditions studied

  • Glenohumeral Arthritis

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Keywords

  • Glenohumeral Arthritis
  • Pain
  • Mobilisation
  • Physiotherapy
  • Rehabilitation
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 30 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 40 years and older patients
  • To be diagnosed with GHOA by specialist physician via MRI, US or radiography and physical examination
  • Unilateral shoulder pain lasting more than 2 months seen during daily living activities and at rest

Exclusion criteria

Exclusion Criteria:

Patients with:

  • Severe arthrosis
  • Tumor
  • Cervical radiculopathy
  • Emotional or cognitive problems
  • A neurological disease that causes muscle weakness on the shoulder
  • A skin disease that may affect upper extremity assessment.
  • Frozen shoulder
  • Thoracic outlet syndrome
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    ''Manuel Therapy group''

    This treatment group will be received Manuel Therapy techniques and exercise interventions.

    Other: Manuel Therapy plus Exercise Intervention

  • Experimental
    ''Exercise group''

    This treatment group will be received only exercise interventions.

    Other: Exercise Intervention

Interventions

  • OtherManuel Therapy plus Exercise Intervention

    Shoulder mobilization techniques include glenohumeral traction, anterior, posterior and inferior glide. We will also use anterior, posterior and inferior joint stretching exercises and scapular mobilization. Exercise interventions include range of motion exercises, stretching exercises, strengthening exercises, and pendulum exercises.

  • OtherExercise Intervention

    Exercise interventions include range of motion exercises, stretching exercises, strengthening exercises, and pendulum exercises.

06

What researchers measure

Primary outcomes

  1. Shoulder Range of Motion (ROM)

    The shoulder flexion, abduction, internal and external rotation ROM will be evaluated with digital goniometer while the patient will be in supine position.

    Time frame: Evaluation will be performed first time at baseline and second time will be performed after 5 weeks rehabilitation program. After treatment "change" will be assessed.

Secondary outcomes

  1. ASES (The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment) Form

    ASES is an assessment form prepared by shoulder and elbow surgeons with objective and subjective sections. The total score is at least 0 and at most 100, and the high scores are positively correlated with the normal function.

    Time frame: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.

  2. Visual Analogue Scale (VAS)

    The levels of pain is felted at rest / activity / night will be measured using Visual Analogue Scale (VAS).Patients will be asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain.

    Time frame: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.

  3. Manual Muscle Test

    Manual Muscle Test is a procedure for the evaluation of strength of individual muscle or muscles group, based upon the effective performance of a movement in relation to the forces of gravity or manual resistance through the available ROM.

    Time frame: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.

  4. Short Form 12 (SF-12)

    SF-12 will be used to assess physical and mental health-related quality of life. The total score is at least 0 and at most 100, and the high scores are positively correlated with high quality of life.

    Time frame: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.

  5. Global Rating of Change (GRC) Scale

    Global Rating of Change (GRC) scale will be used to assess the overall satisfaction levels of the patients. Patients will be asked to evaluate their post-treatment status with a 5-point likert scale and high scores are positively correlated with satisfaction.

    Time frame: Evaluation will be performed after 5 weeks rehabilitation program.

  6. The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire

    DASH questionnaire inquires about the activities of a person in daily life, the degree of participation in recreational activities, the symptom and psychosocial state that affects their pain, emotional state and sleep quality. The total score is at least 0 and at most 100, and the high scores are positively correlated with the increased functional impairment.

    Time frame: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.

07

Study locations

1 site
  • Istanbul University
    Bakırköy, Istanbul 34180, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03958227
Lead sponsor
Istanbul University
Responsible party
Sibel Gayretli Atan (Physiotherapist, Istanbul University) — Principal investigator
First posted
May 21, 2019
Start date
May 20, 2019
Primary completion
Nov 29, 2019
Completion
Dec 30, 2019
Last update
Jan 2, 2020

Study contacts

Sibel Gayretli Atan
principal investigator · sssibel_38@hotmail.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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