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Sex-Based Comparison of the Effects of a Combined Program of Myofascial Release, Codman and Elastic Band Exercises, on Pain, Range of Motion, and Function in Patients with Frozen Shoulder

Protocol summary

Study aim
To evaluate the effectiveness of a combined program of myofascial release, Codman exercises, and elastic-band training on pain, ROM, and function in men and women with frozen shoulder, and compare outcomes by sex.
Design
A randomized, single-blind, factorial, controlled clinical trial on 128 patients. The sample size was calculated using G*Power 3.1 software.
Settings and conduct
The study was conducted at Arvand Physiotherapy Clinic, Tehran. Participants were stratified by sex and randomly allocated to intervention and control groups. Assessments were performed before and after the 8-week intervention by a blinded assessor.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Idiopathic frozen shoulder (35–60 years), Non Athletic lifestyle, chronic pain (≥3 months), VAS ≥3, and restricted ROM (abduction <135°, external rotation <40°, flexion <120°). Exclusion criteria: Anti-inflammatory drug use, secondary shoulder pathology, and session non-attendance.
Intervention groups
Pain, shoulder (ROM), and functional disability were assessed in both groups using the VAS, a standard goniometer and the DASH/SPADI questionnaires. The intervention group underwent an 8-week program consisting of three sessions per week (45–60 minutes each) involving myofascial release, Codman’s pendulum exercises, and elastic band exercises while the control group was monitored via phone calls and text messages during this period and received treatment after the study concluded.
Main outcome variables
Pain, range of motion (ROM), and function indices

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260813070635N1
Registration date: 2026-09-03, 1405/06/12
Registration timing: prospective

Last update: 2026-09-03, 1405/06/12
Update count: 0
Registration date
2026-09-03, 1405/06/12
Registrant information
Name
Niloofar Kashani Siadat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2232 9237
Email address
siadatneli@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-10-10, 1405/07/18
Expected recruitment end date
2026-12-07, 1405/09/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Sex-Based Comparison of the Effects of a Combined Program of Myofascial Release, Codman and Elastic Band Exercises, on Pain, Range of Motion, and Function in Patients with Frozen Shoulder
Public title
Sex-Based Comparison of the Effects of a Combined Program of Myofascial Release, Codman and Elastic Band Exercises, on Pain, Range of Motion, and Function in Patients with Frozen Shoulder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 35 and 60 years. Idiopathic FS diagnosed by a specialist, a non athletic lifestyle. Chronic shoulder pain for ≥3 months Pain severity ≥3 on the VAS. Motion limitation (abduction <135°, external rotation <40°, flexion <120°).
Exclusion criteria:
Use of corticosteroids or anti inflammatory drugs. History of secondary shoulder pathology. Absence from ≥3 consecutive or ≥2 non consecutive intervention sessions.
Age
From 35 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
We reviewed the records of patients who had visited the clinic with shoulder pain—confirmed by an orthopedist—and classified them by gender. Within each gender category, the participants' records were assigned—using a completely random process and in equal numbers—to female control, female intervention, male control, and male intervention groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
“Outcome assessments were performed by an assessor who was blinded to group allocation. Due to the nature of the intervention, the participants and intervention provider could not be blinded
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Science and Research Branch
Street address
University Square, Shohadaye Hesarak Boulevard, End of Shahid Sattari Expressway
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Approval date
2024-08-31, 1403/06/10
Ethics committee reference number
IR.IAU.SRB.REC.1403.296

Health conditions studied

1

Description of health condition studied
Idiopathic frozen shoulder (adhesive capsulitis), characterized by shoulder pain, stiffness, restricted range of motion, and functional impairment.
ICD-10 code
M75.0
ICD-10 code description
XIII – Diseases of the musculoskeletal system and connective tissue

Primary outcomes

1

Description
Pain intensity
Timepoint
Baseline and immediately after the 8-week intervention
Method of measurement
Visual Analog Scale (VAS)

2

Description
Shoulder range of motion (ROM)
Timepoint
Baseline and immediately after the 8-week intervention
Method of measurement
Universal goniometer, measuring shoulder flexion, abduction, and external rotation

3

Description
Shoulder functional disability
Timepoint
Baseline and immediately after the 8-week intervention
Method of measurement
Disabilities of the Arm, Shoulder and Hand (DASH) and Shoulder Pain and Disability Index (SPADI) questionnaires

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The Female intervention group underwent an 8-week supervised combined rehabilitation program, consisting of three sessions per week, each lasting 45 to 55 minutes. The program included 7 minutes of myofascial release (MFR) targeting the shoulder complex using gentle stretching, sustained manual pressure, and slow, multi-directional strokes; Codman’s pendulum exercises performed with minimal active shoulder muscle engagement and progressive advancement; and elastic band exercises involving shoulder flexion, extension, abduction, adduction, and internal/external rotation. Resistance, repetitions, and exercise progression were adjusted based on the Borg RPE scale and individual therapeutic response.
Category
Rehabilitation

2

Description
Intervention group: The men in the intervention group underwent an 8-week supervised combined rehabilitation program, consisting of three sessions per week, with each session lasting 45 to 55 minutes. The program comprised 7 minutes of myofascial release (MFR) targeting the shoulder complex using gentle stretching, sustained manual pressure, and slow, multi-directional strokes; Codman’s pendulum exercises performed with minimal active shoulder muscle engagement and progressive advancement; and elastic band exercises involving shoulder flexion, extension, abduction, adduction, and internal/external rotation. Resistance, repetitions, and exercise progression were adjusted based on the Borg RPE scale and individual therapeutic response.
Category
Rehabilitation

3

Description
Control group: Control Group: Following the initial assessments, the men and women in the control group were informed that they would be contacted after eight weeks to begin therapeutic interventions. Additionally, they were contacted weekly throughout this eight-week period to monitor their well-being and provide psychological support.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Arvand Phhysiotheraoy
Full name of responsible person
Niloofar Kashani Siadat
Street address
Unit 21, No. 3, 1st Baharestan Alley, Kimasi Street, East Hafez Street, Kazem-Abad Neighborhood, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1665683872
Phone
+98 21 2232 9237
Email
siadatneli@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Reza Radfar
Street address
Hesarak, Daneshgah Boulevard, Tehran Province, Greater Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5239
Email
eceres@srbiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Niloofar Kashani Siadat
Position
Graduate student
Latest degree
Master
Other areas of specialty/work
Others
Street address
No. 3, 1st Baharestan Alley, Kimasi Street, East Hafez Street, Kazem-Abad Neighborhood, Pasdaran Street.
City
Tehran
Province
Tehran
Postal code
1665683872
Phone
+98 21 2232 9237
Fax
Email
siadatneli@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Niloofar Kashani Siadat
Position
Graduate student
Latest degree
Master
Other areas of specialty/work
Others
Street address
No. 3, 1st Baharestan Alley, Kimasi Street, East Hafez Street, Kazem-Abad Neighborhood, Pasdaran Street.
City
Tehran
Province
Tehran
Postal code
1665683872
Phone
+98 21 2232 9237
Fax
Email
siadatneli@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Niloofar Kashani Siadat
Position
Graduate student
Latest degree
Master
Other areas of specialty/work
Others
Street address
No. 3, 1st Baharestan Alley, Kimasi Street, East Hafez Street, Kazem-Abad Neighborhood, Pasdaran Street.
City
Tehran
Province
Tehran
Postal code
1665683872
Phone
+98 21 2232 9237
Fax
Email
siadatneli@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
There is no further information
When the data will become available and for how long
3 month after publish
To whom data/document is available
Everyone
Under which criteria data/document could be used
For research and rehabilitation
From where data/document is obtainable
Email: siadatneli@gmail.com
What processes are involved for a request to access data/document
One week is required to gather the necessary data and provide it to the requester.
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