Effects of Baduanjin Exercise Versus Instrument-Assisted Soft Tissue Mobilization on Erector Spinae Muscle Spasm in IT Workers: A Randomized Controlled Trial

To compare the effectiveness of Baduanjin exercises versus Instrument Assisted Soft Tissue Mobilization (IASTM), both combined with hot packs, on reducing pain, muscle spasm, functional disability, and improving lumbar range of motion among IT workers in Gujranwala with erector spinae spasms.

A two-arm, multi-center, parallel-group, single-blind, randomized clinical trial with 120 planned participants. Individuals were randomly allocated in a 1:1 ratio using a computerized sequence via an online randomizer with allocation concealment to maintain participant-level blinding.

This single-centered trial was conducted in Mega NADRA office in Gujranwala, Pakistan.

Inclusion Criteria: IT workers (20–45 years) diagnosed with erector spinae spasms, localized tenderness, palpable trigger points, NPRS score :> 2/10, and ODI score between 0% and 40%. Exclusion Criteria: Spinal pathologies (tumors, infections, fractures), lumbar surgery within 6 months, severe cardiac conditions, active skin lesions, or pregnancy.

Group A (Baduanjin): Received a 10-minute hot pack followed by 20–25 minutes of Baduanjin Qigong exercises (8 movements combining stretching, deep breathing, and focus). Conducted 3 times a week for 4 weeks. Group B (IASTM): Received a 10-minute hot pack followed by 20–25 minutes of Instrument-Assisted Soft Tissue Mobilization (scraping strokes using mechanical tools over the erector spinae muscles). Conducted 3 times a week for 4 weeks.

- Primary Outcome Measures: Pain intensity on the Numeric Pain Rating Scale (NPRS) and lumbar functional disability via the Oswestry Disability Index (ODI). - Secondary Outcome Measures: Active lumbar spine flexion and extension range of motion (ROM) measured by an inclinometer, and physical palpation findings for muscle spasm.

Method of Randomization: Simple Randomization was used to distribute the study participants. The distribution of assignments followed a fixed 1:1 allocation ratio, ensuring that participants had an equal probability of being assigned to either treatment arm. Unit of Randomization: The unit of randomization was the individual participant (adult IT professionals formally diagnosed with erector spinae muscle spasm). Cluster or group-based randomization was not utilized. Randomization Strata: Stratified randomization was not applicable (N/A) for this study, as no pre-enrollment stratification or subgroup blocking (e.g., separating by gender or specific age bands) was carried out prior to assignment. Tools Used in Randomization: The primary tool used to generate the random assignments was an automated computer program, specifically the Online Research Randomizer tool. How the Random Sequence was Built: A random sequence was electronically built and generated by the software program. This computerized sequence dictated whether an enrolling individual would enter Group A (Baduanjin Exercise program) or Group B (Instrument-Assisted Soft Tissue Mobilization). Allocation Concealment:Yes, allocation concealment was carried out. To safeguard against selection bias, the generated random allocation sequence was concealed from the study participants. Participants were kept fully blinded to their specific group allocation; only specific research team members handling data logistics held access to the generated sequence.

To ensure transparency and minimize potential bias, the blinding procedures used in this randomized controlled trial are described below. Participants: Participants were blinded to group allocation. They were not informed whether they were assigned to the Baduanjin exercise group or the Instrument-Assisted Soft Tissue Mobilization (IASTM) group. Allocation details and the randomization sequence were concealed from participants throughout the study period. Treating Physiotherapists: Blinding of the physiotherapists delivering the interventions was not feasible due to the nature of the treatments. The physiotherapists were required to know whether participants were receiving supervised Baduanjin exercises or IASTM in order to administer the interventions appropriately. Principal Investigators and Data Collectors: The principal investigators and data collectors responsible for coordinating treatment sessions, monitoring adherence, and maintaining study records were not blinded to group allocation. Outcome Assessors and Data Analysts: Outcome assessment and statistical analysis were conducted by members of the research team who had access to the allocation information. Therefore, outcome assessors and data analysts were not blinded. Data Safety Monitoring Board (DSMB) and Manuscript Preparation: No independent Data Safety Monitoring Board was established for this institutional study. Manuscript preparation was undertaken by members of the research team who had access to the unblinded study data during data interpretation and reporting.

The study will share a de-identified dataset containing demographic information and outcome measures (NPRS, ODI, and lumbar ROM). The study protocol detailing methodology, interventions, and analysis procedures will also be available. Blank informed consent forms and assessment tools used in the study will be shared upon request. Statistical analysis outputs may be provided for verification purposes. All shared data will be anonymized to protect participant confidentiality. Documents will be made available electronically upon reasonable request to the research team.

The Individual Participant Data (IPD) dataset, Study Protocol, and Statistical Analysis Plan (SAP) will become available to qualified researchers beginning six months after the official publication of the final summary data results. This data will remain accessible for a period of up to three years from the initial start date of availability.

The de-identified Individual Participant Data (IPD) and supporting clinical trial documents will be made available strictly to qualified academic researchers, physical therapy clinicians, and medical investigators affiliated with recognized academic institutions, universities, or healthcare organizations. Access will not be extended to commercial businesses, industry corporations, or entities seeking the data for commercial profit. All applicants must submit a methodologically sound research proposal demonstrating that the dataset will be utilized solely to achieve the scientific objectives specified in their approved study protocol.

he de-identified Individual Participant Data (IPD) and clinical trial documents will be shared strictly for academic research, scientific verification, or secondary meta-analyses. Data will be securely transmitted electronically in spreadsheet formats once the applicant signs a formal Data Use Agreement prohibiting any participant re-identification. Requests will be evaluated by an internal Scientific Review Committee based on the methodological soundness and scientific validity of the proposed research protocol.

The Individual Participant Data (IPD) dataset, clinical trial protocol, and Statistical Analysis Plan (SAP) are obtainable directly from the clinical trial's supervisor and principal investigators at the executing academic institution. The preferred mode of communication for data requests is via formal electronic mail. Clear Contact Information: Contact Person / Supervisor:** Dr. Noha Arshad, Dr.Minahil Zahir, and Dr. Samia Nawaz Affiliated Department:** Department of Physical Therapy Institutional Mailing Address:** Gujranwala Institute of Medical and Emerging Sciences (GIMES), Ali Pur Chatha Road, Near Gujranwala Medical College, Gujranwala, Punjab, Pakistan Primary Email Address:** info@gimes.com.pk Telephone / Contact Number:** +92 321 111 9104 (Alternate: +92 321 111 9105)

Interested researchers should submit a written request describing the study objectives, methodology, and intended use of the data. Requests will be reviewed by the principal investigator and research team within approximately 2–4 weeks. Upon approval and completion of any required data-sharing agreement, the requested documents and de-identified dataset will be provided electronically.

No personally identifiable participant information will be shared. Data will be provided in accordance with ethical approval requirements, participant confidentiality protections, and applicable institutional policies.