The effects of proprioceptive neuromuscular facilitation (PNF) and elastic band trainings on pain and range of motion in women with frozen shoulder syndrome
The effects of proprioceptive neuromuscular facilitation and elastic band trainings on pain and range of motion in women with frozen shoulder syndrome
Design
A randomized, single-blind clinical trial with two experimental groups and one control group will be conducted on 39 female patients diagnosed with frozen shoulder syndrome.
Settings and conduct
The study at Arak University will randomly assign participants to three groups: proprioceptive training, elastic band exercises, or control. Interventions will run for six weeks, three sessions per week. While participants and therapists are aware of the interventions, the outcome assessor will remain blinded to reduce evaluation bias.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 1.Ageed 35 to 50 years. 2.Female gender. 3.Presence of night pain or pain during activities. 4.Diagnosis of frozen shoulder by a physician. 5.No structural damage in the shoulder joint
Exclusion Criteria: 1.Absence from more than 2 consecutive or 3 non consecutive training sessions. 2.Unwillingness to continue participation in the study. 3.Muscular, joint, or bone injuries occurring during the study
Intervention groups
Intervention Group 1: Female patients with frozen shoulder who receive proprioceptive neuromuscular training to evaluate its effect on shoulder range of motion and pain.
Intervention Group 2: Female patients with frozen shoulder who perform resistance exercises using elastic bands to assess their impact on shoulder range of motion and pain.
Control Group: Female patients with frozen shoulder who will not receive any exercise intervention.
Main outcome variables
Shoulder pain; Shoulder range of motion; Upper limb functional performance; Shoulder related quality of life; Patient satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250709066423N1
Registration date:2025-10-02, 1404/07/10
Registration timing:prospective
Last update:2025-10-02, 1404/07/10
Update count:0
Registration date
2025-10-02, 1404/07/10
Registrant information
Name
Mitra Salehi
Name of organization / entity
The University of Arak
Country
Iran (Islamic Republic of)
Phone
+98 21 3300 9876
Email address
m-salehi.03@msc.araku.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-17, 1404/07/25
Expected recruitment end date
2025-12-11, 1404/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of proprioceptive neuromuscular facilitation (PNF) and elastic band trainings on pain and range of motion in women with frozen shoulder syndrome
Public title
Investigating the effect of two types of exercise on shoulder pain and mobility in women with frozen shoulder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Female gender
Age between 35 and 50 years
Diagnosis of frozen shoulder syndrome confirmed by a physician
Presence of pain during daily activities and night pain
No history of trauma, dislocation, or fracture in the upper limb, especially the shoulder joint
No shoulder joint instability
Exclusion criteria:
Absence from more than two consecutive training sessions or three non-consecutive sessions
Lack of willingness to continue participation in the study
Occurrence of muscular, articular, or skeletal injuries during the intervention period
Age
From 35 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
39
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization will be used. The unit of randomization is the individual. The allocation sequence will be generated prior to participant enrollment using a random number table produced in Microsoft Excel.
To ensure allocation concealment, the sequence will be kept by a person who is not involved in the study team. The researcher responsible for recruiting and assessing participants will be blinded to the allocation sequence to minimize the risk of systematic bias.
Each eligible participant, after screening and signing the informed consent form, will be assigned to one of the three study groups (PNF, elastic band, or control) according to the pre-prepared randomization list, following the sequence order.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, due to the nature of the interventions (PNF and elastic band exercises), blinding of participants and the researcher is not possible, as the type of exercise is clearly recognizable to both the participants and the trainer.
Similarly, the personnel responsible for data collection and outcome assessment will also be aware of the group allocations due to the structure of the study.
However, the data analyst, who is responsible for the statistical analysis of the results, will be blinded to group assignments in order to prevent bias in the final analysis.
Group allocation information will be provided to the analyst using specific codes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University
Street address
Arak, Sardasht, Basij Square, Karbala Boulevard, Arak University
City
Arak
Province
Markazi
Postal code
3848177584
Approval date
2025-06-18, 1404/03/28
Ethics committee reference number
IR.ARAKU.REC.1404.015
Health conditions studied
1
Description of health condition studied
Frozen shoulder syndrome
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder
Primary outcomes
1
Description
Range of motion of the shoulder joint
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Using a goniometer
Secondary outcomes
1
Description
Pain in the shoulder joint
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Using a visual analogue scale
Intervention groups
1
Description
Intervention Group: Proprioceptive Neuromuscular Facilitation (PNF) Exercises. The training protocol includes stretching movements and PNF motor patterns using the Contract-Relax (CR) and Hold-Relax (HR) techniques, specifically targeting the shoulder joint and the surrounding musculature—particularly the flexors, extensors, abductors, and internal and external rotators. Participants will perform movements with manual resistance provided by the instructor, either in a supine or seated position. No specialized equipment is required other than a therapeutic mat. Subjects will participate in three 30-minute sessions per week over a six-week period. Each session consists of approximately five minutes of warm-up with gentle stretching, followed by around twenty minutes of PNF techniques involving three sets of each movement (each set comprising a 10-second isometric contraction and a 30-second passive stretch), and concludes with five minutes of cool-down using light stretching exercises. The intensity of the exercises will be progressively adjusted based on each participant’s pain tolerance threshold.
Category
Rehabilitation
2
Description
Intervention Group: Elastic Band Exercises. The intervention group will perform resistance training using Grade 2 elastic bands, targeting the muscles surrounding the shoulder joint—specifically the flexors, extensors, abductors, and internal and external rotators. Participants will engage in three sessions per week over a six-week period. Each session lasts approximately 30 minutes and includes five minutes of warm-up, twenty minutes of resistance exercises with the band involving shoulder flexion, extension, abduction, adduction, and internal and external rotation (three sets of 10 to 12 repetitions per movement, with one-minute rest intervals between sets), followed by five minutes of cool-down. The resistance level of the band will be progressively increased based on the principle of progressive overload. No equipment other than elastic bands and a chair or wall for stabilization will be used. The intensity of the exercises will be tailored to each participant’s physical capacity and pain tolerance.
Category
Rehabilitation
3
Description
Control group. Participants in the control group will not receive any specific intervention or exercise regimen during the six-week study period and will continue with their routine daily activities. These individuals will be assessed for shoulder range of motion only at the beginning of the study and at the end of the six weeks. To uphold ethical standards, an educational booklet containing appropriate shoulder exercises will be provided to them upon completion of the study.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Clinic Medical Center Building
Full name of responsible person
Shahnaz Shahrjerdi
Street address
Imam Khomeini Street, after 12-Meteri Malek, next to Bank Maskan, Iran Clinic Medical Center Building
City
Arak
Province
Markazi
Postal code
3813846373
Phone
+98 86 3221 5005
Fax
Email
s-shahrjerdi@araku.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Arak
Full name of responsible person
Shahnaz Shahrjerdi
Street address
Arak, Sardasht, Basij Square, Karbala Boulevard, Arak University, Department of Physiology and Sports Pathology
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3262 9024
Email
s-shahrjerdi@araku.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 Arak
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 Arak
Full name of responsible person
Shahnaz Shahrjerdi
Position
PhD in Sports Medicine
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Arak, Sardasht, Basij Square, Karbala Boulevard, Arak University, Department of Physiology and Sports Pathology, Faculty of Sports Sciences
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3262 9024
Email
s-shahrjerdi@araku.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Arak
Full name of responsible person
Shahnaz Shahrjerdi
Position
PhD in Sports Medicine
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Arak, Sardasht, Basij Square, Karbala Boulevard, Arak University, Department of Physiology and Sports Pathology, Faculty of Sports Sciences
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3262 9024
Email
s-shahrjerdi@araku.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Arak
Full name of responsible person
Shahnaz Shahrjerdi
Position
PhD in Sports Medicine
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Arak, Sardasht, Basij Square, Karbala Boulevard, Arak University, Department of Physiology and Sports Pathology, Faculty of Sports Sciences
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3262 9024
Email
s-shahrjerdi@araku.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
All research data will be made available after publication of the study results, except for any data that could potentially lead to the identification of participants. Only de-identified datasets or aggregated information related to the primary outcome variables will be shared, if required.
When the data will become available and for how long
5 months after the publication of the results.
To whom data/document is available
All individuals, researchers, professors, and patients with frozen shoulder can benefit from this study.
Under which criteria data/document could be used
Individuals interested in studying the research can contact the researcher via email to access the documents.
From where data/document is obtainable
Initially, please contact Dr. Shahrjerdi via email at s-shahrjerdi@araku.ac.ir, and then follow up by phone at +98-9912016283. It is also possible to visit the Library of Arak University, located in Sardasht, Basij Square, Karbala Boulevard, Arak University.
What processes are involved for a request to access data/document
Researchers can receive the requested document after sending an email and obtaining approval from the researcher.