NCT06886334: FDT

Flexion-Distraction Technique

Not yet recruiting Phase 1, PHASE2 Last updated 20 March 2025

What this trial tests

Phase 1, PHASE2 trial testing exercise in Lumbar Disc Herniation in 68 participants. Not yet recruiting.

Timeline

2 April 2025

Primary endpoint
3 April 2026

1 May 2026

Quick facts

Lead sponsor	Istanbul Medipol University Hospital
Phase	Phase 1, PHASE2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	68
Start date	2 April 2025
Primary completion	3 April 2026
Estimated completion	1 May 2026

Drugs / interventions tested

• exercise
• mobilization

Conditions studied

• Lumbar Disc Herniation — all drugs for Lumbar Disc Herniation →

Sponsor

Istanbul Medipol University Hospital

Who can join

Adults 30 to 60, any sex, with Lumbar Disc Herniation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study is to compare the effects of conventional physical therapy and flexion-distraction (Cox technique) on pain, functional capacity, and quality of life in patients with lumbar disc herniation (LDH) receiving non-surgical treatment. The study will include two groups: one group will receive conventional physical therapy (ultrasound, transcutaneous electrical nerve stimulation (TENS), heat application, and home exercises), while the other group will receive heat application, the Cox technique, and home exercises. The effectiveness of these two methods will be compared to determine the most appropriate approach for LDH treatment.

The study will include individuals aged 30-60 diagnosed with L4-L5 disc herniation who apply to the Physical Medicine and Rehabilitation Department of Bursa VM Medical Park Hospital and Nilüfer Spine Health Center. Two groups of 34 participants each will be formed, and randomization will be based on the participants' preferred treatment center. The groups will be named the conventional physical therapy group (CPTG) and the Cox technique treatment group (CTTG).

Assessment parameters will include pain (visual analog scale (VAS) and algometry), range of motion (digital goniometer), functional capacity (Oswestry Disability Index - ODI), and quality of life (SF-36 Quality of Life Scale). Evaluations will be conducted by the same expert physiotherapist.

The treatment protocols are as follows:

Conventional Physical Therapy Group (CPTG): Ultrasound (4 minutes), TENS (100 Hz, 20 minutes), heat application (15 minutes), and home exercises will be applied. Treatment will be conducted three times a week for four weeks.

Flexion-Distraction Group (Cox Technique) (CTTG): In addition to heat application (15 minutes) and home exercises, the Cox technique will be used. The patient will be placed face down on a specialized table, and traction will be applied to the lumbar spine for 10 minutes.

Both groups will perform pelvic tilt, hip flexor stretching, hamstring stretching, cat-camel, bridge, and straight leg raise exercises, each repeated ten times.

The sample size was determined based on a study by Martinez et al., and a total of 68 participants will be included. Power analysis using the G\*Power 3.1 program calculated the minimum sample size as 68.

Data will be analyzed using SPSS 25.0 software. Normal distribution will be evaluated using the Kolmogorov-Smirnov and Shapiro-Wilk tests. Parametric or non-parametric tests will be applied accordingly. Differences between groups will be analyzed using an independent samples t-test or the Mann-Whitney U test. Correlation analyses will be performed using Pearson or Spearman methods, and regression analyses will be applied to examine variable relationships.

The results of this study will contribute to determining the most effective conservative treatment approach for LDH patients by comparing the effectiveness of conventional physical therapy and the Cox technique.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.