Chronic Lumbar Disc Herniation: A Randomized Single-Blind Study on the Comparative Efficacy of Peloid Therapy Versus Hot Pack Therapy
Phase: NA
Conditions: Lumbal Disc Herniation
Sponsor: Fenerbahce University

Study Protocol and Statistical Analysis Plan
Document Title: Chronic Lumbar Disc Herniation: A Randomized Single-Blind Study on the
Comparative Efficacy of Peloid therapy Versus Hot pack Therapy
NCT Number: NCTXXXXXXXX
Document Date: July 20, 2025
Study Protocol
Study Design
This study is a single-blinded, randomized controlled trial involving 60 individuals diagnosed with
chronic lumbar disc herniation (LDH). Participants were randomly assigned into two groups: peloid
therapy + TENS and hotpack therapy + TENS. Each group received treatment for 3 weeks (15
sessions).
Inclusion Criteria
Adults aged 18-50 with LDH symptoms for more than 3 months, confirmed by MRI, without
physiotherapy in the last 6 months.
Exclusion Criteria
Severe neurological deficit, malignancy, osteoporosis, inflammatory diseases, systemic disorders, or
contraindications for therapy were excluded.
Interventions
Peloid therapy was applied at 45°C for 30 minutes; hotpack therapy at 90°C for 20 minutes. Both
followed by 20 minutes of conventional TENS.

Study Protocol and Statistical Analysis Plan
Outcome Measures
Primary outcomes include pain (VAS), disability (ODI), and functionality (BPFS). Secondary
outcomes include quality of life (SF-36), ROM, and finger-floor distance. Assessments were
performed pre- and post-treatment.
Statistical Analysis Plan
Sample size was determined using G*Power software based on an effect size of 0.759 from a prior
study. A total of 42 participants were required to detect significant differences with 95% confidence
and 5% alpha error.
SPSS 22.0 software was used. Descriptive statistics included mean, standard deviation, frequency,
and percentage. Between-group differences were analyzed using independent samples t-tests and
chi-square tests. Within-group comparisons were conducted using paired samples t-tests. A p-value
< 0.05 was considered statistically significant.