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IRCT20211201053244N7 IRCT 2026-05-02 University of Sistan and Baluchistan Effect of massage therapy and Dynamic Neuromuscular Stabilization exercises on pain, disability, and quality of life in men with chronic low back pain Comparison of the effects of massage therapy, Dynamic Neuromuscular Stabilization exercises, and their combination on pain intensity, functional disability, and quality of life in men aged 45 to 65 years with chronic non-specific low back pain 2026-05-10 anticipated 60 Complete https://irct.ir/trial/88355 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Three-arm, parallel-group, randomized clinical trial with pretest-posttest assessment, Randomization description: After baseline assessment and confirmation of eligibility, participants will be randomly allocated in a 1:1:1 ratio to three parallel groups: Dynamic Neuromuscular Stabilization exercise, massage therapy, and combined Dynamic Neuromuscular Stabilization plus massage therapy. The unit of randomization is the individual participant. A computer-generated simple random sequence will be used. The allocation sequence will be prepared by a researcher not involved in recruitment or outcome assessment, and assignments will be placed in sequentially numbered, opaque, sealed envelopes to ensure allocation concealment. No stratification will be used, Blinding description: Due to the nature of the physical interventions (Dynamic Neuromuscular Stabilization exercises and massage therapy), blinding of the participants and care providers (therapists/instructors) is not possible. However, to minimize detection and performance bias, the outcome assessor responsible for administering the questionnaires (VAS, Oswestry Disability Index, and SF-36) will be strictly blinded to the participants' group allocations. Furthermore, the data analyst will be blinded by receiving a coded dataset (e.g., Groups A, B, and C) without revealing the actual intervention assigned to each code. N/A Chronic nonspecific low back pain. Intervention 1: Intervention group 1: Twenty participants will receive Dynamic Neuromuscular Stabilization exercises for 6 weeks, 3 sessions per week, 45 minutes per session. Each session will include 10 minutes of warm up, 25 minutes of Dynamic Neuromuscular Stabilization exercises, and 10 minutes of cool down. The exercise intensity will be progressively adjusted according to participants’ tolerance and feedback. The program will include diaphragmatic breathing, baby rock, bridge, bear crawl, side lying hip abduction, dead bug, and single leg bridge exercises. Intervention 2: Intervention group 2: Twenty participants will receive Swedish massage therapy for 6 weeks, 3 sessions per week, 30 minutes per session, administered by a trained massage therapist. The massage protocol will include effleurage, petrissage, and friction techniques applied to the lumbar and surrounding muscles. The duration of each session will be approximately 5 minutes of effleurage, 15 minutes of petrissage, and 10 minutes of friction. Intervention 3: Intervention group 3: Twenty participants will receive a combined intervention for 6 weeks, 3 sessions per week. Each session will include 45 minutes of Dynamic Neuromuscular Stabilization exercises and 30 minutes of Swedish massage therapy. The exercise component will consist of warm up, Dynamic Neuromuscular Stabilization exercises, and cool down. The massage component will include effleurage, petrissage, and friction techniques administered by a trained massage therapist. No - There is not a plan to make this available Justification or reason for not sharing IPD is The data collected is part of a Master's thesis and belongs to the University of Sistan and Baluchestan. Sharing raw participant data is not currently covered by the institutional ethical approval or participant consent forms. There is no further information.
public Mohammadreza Rezaeipour
Faculty of Education and Psychology, University of Sistan and Baluchestan, Daneshgah Blvd., Zahedan, Sistan and Baluchestan Province, Iran
Zahedan Iran (Islamic Republic of) 9816745639 +98 54 3113 2674 rezaeipour@ped.usb.ac.ir University of Sistan and Baluchestan scientific Mohammadreza Rezaeipour
Faculty of Education and Psychology, University of Sistan and Baluchestan, Daneshgah Blvd., Zahedan, Iran
Zahedan Iran (Islamic Republic of) 9816745639 +98 54 3113 2674 rezaeipour@ped.usb.ac.ir University of Sistan and Baluchestan Iran (Islamic Republic of) Men aged 45 to 65 years. Diagnosis of chronic non-specific low back pain lasting at least 3 months. No participation in similar exercise programs during the previous 6 months. Ability to attend intervention sessions and complete study assessments. Provision of written informed consent. 45 years 65 years Male Specific causes of low back pain, including disc herniation, spinal stenosis, or vertebral fracture. Severe injury of the spine, hip, knee, or ankle. Presence of other diseases that interfere with safe participation or study outcomes. Use of medications that significantly affect pain or physical function. M54.5 Low back pain Rehabilitation Rehabilitation Rehabilitation Intervention group 1: Twenty participants will receive Dynamic Neuromuscular Stabilization exercises for 6 weeks, 3 sessions per week, 45 minutes per session. Each session will include 10 minutes of warm up, 25 minutes of Dynamic Neuromuscular Stabilization exercises, and 10 minutes of cool down. The exercise intensity will be progressively adjusted according to participants’ tolerance and feedback. The program will include diaphragmatic breathing, baby rock, bridge, bear crawl, side lying hip abduction, dead bug, and single leg bridge exercises. Intervention group 2: Twenty participants will receive Swedish massage therapy for 6 weeks, 3 sessions per week, 30 minutes per session, administered by a trained massage therapist. The massage protocol will include effleurage, petrissage, and friction techniques applied to the lumbar and surrounding muscles. The duration of each session will be approximately 5 minutes of effleurage, 15 minutes of petrissage, and 10 minutes of friction. Intervention group 3: Twenty participants will receive a combined intervention for 6 weeks, 3 sessions per week. Each session will include 45 minutes of Dynamic Neuromuscular Stabilization exercises and 30 minutes of Swedish massage therapy. The exercise component will consist of warm up, Dynamic Neuromuscular Stabilization exercises, and cool down. The massage component will include effleurage, petrissage, and friction techniques administered by a trained massage therapist. Pain intensity score. Timepoint: Baseline (before the start of the intervention) and exactly 6 weeks after the start of the intervention. Method of measurement: Visual Analogue Scale. Functional disability score. Timepoint: Baseline (before the start of the intervention) and exactly 6 weeks after the start of the intervention. Method of measurement: Oswestry Disability Index questionnaire. Quality of life score. Timepoint: Baseline (before the start of the intervention) and exactly 6 weeks after the start of the intervention. Method of measurement: 36-Item Short Form Health Survey questionnaire. University of Sistan and Baluchistan Approved 2025-11-05 Ethics Committee of Sistan and Baluchestan University University Street Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)