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

Compare the effects of six weeks of massage, Dynamic Neuromuscular Stabilization exercises, and their combination on pain, disability, and quality of life in men with chronic non-specific low back pain.

A randomized, three-arm parallel group clinical trial on 60 patients. A computer-generated simple random sequence will be used for allocation. This study is not blinded for participants but includes blinded outcome assessment and blinded data analysis.

The study will be conducted at rehabilitation centers affiliated with the University of Sistan and Baluchestan. After obtaining informed consent and baseline assessments, patients will be randomly allocated into three groups. After 6 weeks of intervention, post-test evaluations will be performed. Due to the physical nature of the interventions, participants and therapists cannot be blinded. However, the outcome assessor evaluating the questionnaires and the statistical data analyst will be strictly blinded to the group allocations.

Inclusion: Men aged 45 to 65 years; chronic non-specific low back pain for at least 3 months; no similar exercises in the past 6 months. Exclusion: Specific causes of back pain (e.g., disc herniation, fractures); severe spinal or limb injuries; medications affecting pain or function; interfering diseases.

Group 1: Dynamic Neuromuscular Stabilization exercises (3 sessions/week, 45 minutes) for 6 weeks. Group 2: Swedish massage (3 sessions/week, 30 minutes) for 6 weeks. Group 3: Combined exercises and massage for 6 weeks.

Pain intensity; Functional disability; Quality of life.

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.

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.

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.

Study protocol registered in the Iranian Registry of Clinical Trials; statistical analysis plan described in the approved thesis proposal and final thesis; final clinical study report in the form of the approved Master’s thesis and any published article derived from the study. No individual participant data, informed consent forms, or analytic code will be shared.

The study protocol will be available after trial registration. The statistical analysis plan and final clinical study report will be available after thesis approval and completion of the study. These documents will remain available for 5 years after thesis approval or publication of the main results, whichever occurs later.

These documents will be available to researchers affiliated with academic or research institutions.

Access will be granted for academic and non commercial scientific use only. Applicants must submit a written request describing the research purpose and intended use of the documents. Use of the documents requires proper citation of the original study and approval by the principal investigator and supervisor.

The study protocol will be obtainable from the Iranian Registry of Clinical Trials public record. The statistical analysis plan and final clinical study report may be requested by email from the study team. Contact persons: Mohammadamin Keyvanshokouh, amin.keyvanshokuh@gmail.com; Mohammadreza Rezaeipour, rezaeipour@ped.usb.ac.ir.

Applicants should send a written email request including their affiliation, research objective, and intended use of the requested documents. Requests will be reviewed by the study team within 2 to 4 weeks. If approved, the documents will be sent electronically in portable document format.

No further information.