Flexion-Distraction Technique

Phase 1

Not yet recruiting

• Conditions: Lumbar Disc Herniation

• Registration Number: NCT06886334
• Lead Sponsor: Istanbul Medipol University Hospital

Brief Summary

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.

Detailed 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. 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 evaluated to determine the most appropriate approach for LDH treatment.

LDH is a condition in which damage to the disc structures compresses the nerve roots, causing pain, numbness, and movement limitations in the lower back and legs. Non-surgical methods are generally the first choice in treatment and have shown successful results. Conventional physical therapy methods are effective in pain management and functional improvement and are widely used to reduce muscle spasms and inflammation. Ultrasound provides thermal and mechanical effects on deep tissues, while TENS stimulates nerves to relieve pain. Heat application helps muscle relaxation and increases blood circulation.

Flexion-distraction (Cox technique) is a manual therapy method that aims to widen the spinal canal and reduce nerve compression. This technique increases the flexibility of spinal segments, alleviating pain and improving functional capacity. Randomized controlled studies have shown that this method is effective in LDH patients. However, studies directly comparing the Cox technique with conventional physical therapy are limited.

This 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 included, and randomization will be based on the participants' preferred treatment center. The groups will be named the conventional physical therapy group (CTG) and the Cox technique treatment group (CTG).

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

The treatment protocols are as follows:

1. Conventional Physical Therapy Group (CTG): 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.

2. Flexion-Distraction Group (Cox Technique) (CTG): 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 tests will be used for normally distributed data, while non-parametric tests will be applied otherwise. 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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20
• Study Start: 2025-04-02
• Primary Completion: 2026-04-03
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Being between 30-60 years of age
• Having a diagnosis of L4-L5 lumbar disc herniation
• Not having undergone surgical intervention
• Having no cognitive impairment or intellectual disability
• Providing voluntary participation and written consent

Exclusion Criteria

• Having previously undergone surgical operation in the lumbar region
• Having an oncological diagnosis
• Pregnancy
• Presence of severe physical or psychological disorders that would prevent completion of the study
• Participation in another active physical therapy program

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
subjective pain	through study completion, an average of 6 months	Measurements will be taken in two ways: Visual Analog Scale (VAS): The VAS scale will be used to assess low back pain in individuals with LDH. Participants will mark their pain level on a 10 cm line, where 0 represents "no pain" and 10 represents "very severe pain".
range of motion	through study completion, an average of 6 months	Measurements will be taken using the Baseline goniometer, a digital goniometer. A digital goniometer is a tool used to precisely measure the range of motion of joints. It offers greater accuracy compared to traditional goniometers and displays measurements on a digital screen. Research shows that measurements taken with a digital goniometer provide more consistent results compared to traditional methods. The flexion, extension, lateral flexion, and rotation degrees of the lumbar region will be measured.
objective pain	through study completion, an average of 6 months	Algometer: Measurements will be taken using the Baseline dolorimeter, a device that applies pressure to measure pain threshold. The algometer determines the pressure point at which the patient feels pain, assessing pain tolerance and threshold. Measurements will be taken from the right and left sides of the affected spinal segment

Secondary Outcome Measures

Name	Time	Method
Functional capacity	through study completion, an average of 6 months	Functional capacity will be evaluated using the Oswestry Disability Index (ODI). The ODI is a questionnaire scale designed to assess the impact of low back pain on daily life. It consists of 10 items, each scored from 0 to 5. The total score reflects the patient's functional capacity. The ODI is a widely used and highly valid scale for evaluating the functional status of patients with low back pain
Daily living activities	through study completion, an average of 6 months	Daily living activities will be evaluated using the SF-36 Quality of Life Scale. The SF-36 is a questionnaire designed to assess individuals' overall health status and quality of life, covering both physical and mental health dimensions. It consists of 36 questions, and separate scores are calculated for each dimension. The SF-36 is widely used for quality of life assessment in various populations, and its reliability and validity have been well-established.