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IRCT20250709066423N1 IRCT 2025-10-02 The University of Arak Investigating the effect of two types of exercise on shoulder pain and mobility in women with frozen shoulder The effects of proprioceptive neuromuscular facilitation (PNF) and elastic band trainings on pain and range of motion in women with frozen shoulder syndrome 2025-10-17 anticipated 39 Complete https://irct.ir/trial/84787 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 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. N/A Frozen shoulder syndrome. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Yes - There is a plan to make this available What will be shared: 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: 5 months after the publication of the results. To whom: All individuals, researchers, professors, and patients with frozen shoulder can benefit from this study. Conditions: Individuals interested in studying the research can contact the researcher via email to access the documents. Where to obtain: 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. How to obtain: Researchers can receive the requested document after sending an email and obtaining approval from the researcher. Comments:
public Shahnaz Shahrjerdi
Arak, Sardasht, Basij Square, Karbala Boulevard, Arak University, Department of Physiology and Sports Pathology, Faculty of Sports Sciences
Arak Iran (Islamic Republic of) 3848177584 +98 86 3262 9024 s-shahrjerdi@araku.ac.ir The University of Arak scientific Shahnaz Shahrjerdi
Arak, Sardasht, Basij Square, Karbala Boulevard, Arak University, Department of Physiology and Sports Pathology, Faculty of Sports Sciences
Arak Iran (Islamic Republic of) 3848177584 +98 86 3262 9024 s-shahrjerdi@araku.ac.ir The University of Arak Iran (Islamic Republic of) 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 35 years 50 years Both 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 M75.0 Adhesive capsulitis of shoulder Rehabilitation Rehabilitation N/A 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. 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. 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. 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. 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. The University of Arak Approved 2025-06-18 Ethics Committee of Arak University Arak, Sardasht, Basij Square, Karbala Boulevard, Arak University Arak Markazi Iran (Islamic Republic of)