Comparative Effects of Strain Counterstain Verses Active Release Technique on Nursing Staff of Gujranwala with Plantar Fasciitis: a randomized controlled trial

To compare the effectiveness of Strain Counterstrain (SCS) versus Active Release Technique (ART), each combined with standard physical therapy, on pain, functional ability (FAAM), and ankle range of motion in nursing staff with plantar fasciitis.

A two-arm, multi-center, parallel-group, double-blind, randomized clinical trial with 112 planned participants. Individuals were randomly allocated in a 1:1 ratio using a computerized sequence via the Random.org online randomizer, with allocation concealment to maintain participant-level blinding.

This multi-centered trial was conducted at Chatha Hospital Gujranwala, District Headquarters Hospital Gujranwala, Cheema Heart Complex, and Chaudhary Hospital Gujranwala, Pakistan

Inclusion Criteria: Nursing staff aged 25–60 years with plantar heel pain >4 weeks and tenderness over the plantar medial calcaneal tubercle. Exclusion Criteria: Other foot/ankle disorders, lower limb injury, malignancy, foot deformity or surgery, leg length discrepancy, ankle effusion, prior heel corticosteroid injection, or use of a walking aid.

Group A (SCS): Received a 12-minute standard physical therapy program (ankle ROM, stretching, and intrinsic muscle strengthening) followed by Strain Counterstrain applied to six plantar fascia–related tender points (90 seconds × 5 repetitions, 30-second rest), 3 sessions/week for 6 weeks. Group B (ART): Received the same standard physical therapy program followed by Active Release Technique applied to the same six tender points (5 repetitions, 30-second rest), 3 sessions/week for 6 weeks.

(i) Primary Outcomes: Pain intensity (NPRS) and functional ability (FAAM). (ii) Secondary Outcomes: Ankle range of motion (dorsiflexion, plantarflexion, inversion, and eversion) measured using a universal goniometer.

Method of Randomization: Simple randomization was used to allocate participants in a fixed 1:1 ratio, giving each participant an equal probability of assignment to either treatment arm. Unit of Randomization: The individual participant (nursing staff formally diagnosed with plantar fasciitis). Cluster or group-based randomization was not used. Randomization Strata: Not applicable — no pre-enrollment stratification (e.g., by gender or age band) was performed. Tools Used in Randomization: The online tool available at random.org/lists/ was used to generate the allocation sequence by specifying the total number of participants, participants per group, and group numbers, with unique identification numbers generated for each participant. How the Random Sequence was Built: The electronically generated sequence dictated whether an enrolling individual entered Group A (Strain Counterstain) or Group B (Active Release Technique). Allocation Concealment: Yes. The generated allocation sequence was concealed from participants and from the assessors performing outcome measurements; only research team members handling enrollment logistics had access to the sequence.

Participants: Participants were blinded to group allocation and were not informed whether they were receiving Strain Counterstain or Active Release Technique. Outcome Assessors: Assessors recording NPRS, FAAM, and goniometric ROM at each time point were kept unaware of group allocation to minimize measurement bias. Treating Physiotherapists: Blinding of the treating physiotherapists was not feasible, as they were required to know the assigned technique in order to deliver the intervention correctly. Principal Investigators and Data Analysts: The principal investigators and statisticians responsible for data analysis had access to allocation information and were therefore not blinded.

The study will share a de-identified dataset containing demographic information (age, gender, BMI, affected side, symptom duration) and outcome measures (NPRS, FAAM, and ankle ROM for dorsiflexion, plantarflexion, inversion, and eversion) across all five assessment time points. The study protocol detailing methodology, interventions, and analysis procedures will also be available. Blank informed consent forms and assessment tools used in the study (NPRS, FAAM, goniometer recording sheet) will be shared upon request. Statistical analysis outputs (SPSS v27 outputs for the Mann-Whitney, Friedman, and post-hoc Wilcoxon analyses) 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.

The 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 study's supervisory committee and principal investigators at the executing academic institution. The preferred mode of communication for data requests is via formal electronic mail. Contact Person / Supervisor: Dr. Mubeen Arshad and Dr. Hassan Fayyaz Butt 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: principal@gimes.com.pk, Telephone / Contact Number: +92 321 1119104.

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.