Protocol summary

Study aim
To compare the effectiveness of eight weeks of Codman pendulum exercises with kinesiotape versus Codman exercises alone on pain reduction, range of motion improvement, and shoulder function in women with frozen shoulder.
Design
Design: Randomized clinical trial, two-arm parallel, pretest–posttest, single-center. Randomization: Simple random allocation (random number table or sealed envelopes). Blinding: Assessor- and analyst-blinded (outcome assessor and statistician blinded to group allocation).
Settings and conduct
Setting: Poria-ye Vali Sports Hall, Malayer, Hamedan Province, Iran. Procedures: Recruitment via public call and clinic referrals; baseline assessment (demographics, VAS, goniometer ROM, DASH, WORC); supervised interventions; post-intervention assessment at week 9 using the same measures. Safety measures and taping protocol followed in all sessions.
Participants/Inclusion and exclusion criteria
Women aged 40–60 years with primary frozen shoulder diagnosed by an orthopedic specialist. Sample size: 30 participants (two groups of 15).
Intervention groups
Group 1 (Intervention): Codman pendulum exercises + kinesiotape — 8 weeks, 3 sessions/week, 40 minutes/session. Kinesiotape applied to supraspinatus and deltoid per protocol (skin allergy test before first application). Group 2 (Active control): Codman pendulum exercises only — identical schedule and supervision, without kinesiotape.
Main outcome variables
1. Shoulder pain 2. Shoulder range of motion (flexion, abduction, external rotation) 3. Shoulder function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250923067339N1
Registration date: 2025-11-18, 1404/08/27
Registration timing: prospective

Last update: 2025-11-18, 1404/08/27
Update count: 0
Registration date
2025-11-18, 1404/08/27
Registrant information
Name
Mohadeseh Roostaei
Name of organization / entity
Razi University of Kermanshah
Country
Iran (Islamic Republic of)
Phone
+98 83 3434 3515
Email address
m.roostaei@stu.razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-12, 1404/09/21
Expected recruitment end date
2026-01-12, 1404/10/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Codman exercises with and without kinesiotape on pain, range of motion, and functional tests in women with frozen shoulder
Public title
The effect of Codman exercises with and without kinesiotape on pain, range of motion, and functional tests in women with frozen shoulder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gender: Female Age: 40-60 years Diagnosis of primary frozen shoulder by an orthopedic specialis Presence of shoulder pain for at least 3 months Significant loss of active and passive range of motion of the shoulder joint No use of medication or other shoulder-related treatment Written consent to voluntarily participate in the study
Exclusion criteria:
History of shoulder fracture or dislocation Rotator cuff tear Neuromuscular disorders History of shoulder surgery within the past two years Skin sensitivity to kinesiology tape Missing more than two consecutive sessions of the training program
Age
From 40 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be allocated into two groups using simple randomization based on a random number table (or Random.org). Each eligible participant will receive an ID number, and the allocation will be performed by an independent person not involved in intervention delivery or outcome assessment.
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome assessor will be blinded to group allocation. All data will be coded and provided to the statistician without group labels to ensure blinded analysis. Due to the nature of exercise-based interventions, participant and therapist blinding is not feasible.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Razi University Ethics Committee
Street address
Room 00, Faculty of Sport Sciences, Razi University, Daneshgah St., Taq Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Approval date
2025-09-20, 1404/06/29
Ethics committee reference number
IR.RAZI.REC.1404.026

Health conditions studied

1

Description of health condition studied
Adhesive Capsulitis / Frozen Shoulder
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder

Primary outcomes

1

Description
Shoulder pain level
Timepoint
Before and after eight weeks of intervention
Method of measurement
Visual Analog Scale (VAS)

2

Description
Shoulder range of motion (flexion, abduction, external rotation)
Timepoint
Before and after eight weeks of intervention
Method of measurement
Standard goniometer

3

Description
Shoulder function
Timepoint
Before and after eight weeks of intervention
Method of measurement
DASH and WORC questionnaires

Secondary outcomes

1

Description
Raised hands test
Timepoint
Before and after 8 weeks
Method of measurement
Standard shoulder functional test (Hand to Head Test)

2

Description
Apley Scratch Test
Timepoint
Before and after 8 weeks
Method of measurement
Functional testing of shoulder flexion and rotation

3

Description
Shoulder Rotation Test
Timepoint
Before and after 8 weeks
Method of measurement
Evaluation of the active rotation range of the shoulder joint with a goniometer

4

Description
Changes in daily performance scores
Timepoint
Before and after 8 weeks
Method of measurement
WORC questionnaire performance items

5

Description
Perception of overall improvement from treatment
Timepoint
Before and after 8 weeks
Method of measurement
Participant's mental question (Global Perceived Effect)

Intervention groups

1

Description
Intervention group: Cadman exercises with kinesiotape
Category
Rehabilitation

2

Description
Control group: Cadman exercises without kinesiotape
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Pouriya Vali Sports Hall
Full name of responsible person
Farzaneh Maleki
Street address
Hamzeh Loyy Street, opposite the Martyr Sardar Soleimani School, Amir Kabir Square, Shohada Street
City
Malayer
Province
Hamadan
Postal code
6571861132
Phone
+98 937 314 1367
Email
f.maleki13401340@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Razi
Full name of responsible person
Keyvan Amini
Street address
Taq Bostan, University Street
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4515
Email
kamini@razi.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Razi
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
The University of Razi
Full name of responsible person
Manouchehr Heidari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Room 50, Faculty of Sport Sciences, Razi University, Daneshgah St., Taq Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7609
Email
mhaidary2000@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Razi
Full name of responsible person
Manouchehr Heidari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Room 50, Faculty of Sport Sciences, Razi University, Daneshgah St., Taq Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7609
Email
mhaidary2000@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Razi
Full name of responsible person
Manouchehr Heidari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Room 50, Faculty of Sport Sciences, Razi University, Daneshgah St., Taq Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7609
Email
mhaidary2000@yahoo.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Some of the data can be shared after de-identifying the subjects.
When the data will become available and for how long
3 months after results are published
To whom data/document is available
All persons upon formal request
Under which criteria data/document could be used
درخواست دسترسی به داده ها با هر هدفی مجاز است
From where data/document is obtainable
If you need to receive documents, please send an email to Manouchehr Heidari, Assistant Professor of Pathology and Corrective Exercises Department, Razi University, at the email address: mhaidary2000@yahoo.com.
What processes are involved for a request to access data/document
In case of formal request, stating the relevant reasons and providing full details, the data will be sent via email after 72 hours.
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