Clinical trial NCT06886334: Flexion-Distraction Technique
Official title: Comparison of the Effects of Conventional Physical Therapy and Flexion-Distraction Technique on Pain, Functional Capacity, Activities of Daily Living, and Range of Motion in Patients with Lumbar Disc Herniation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Lumbar Disc Herniation
Keywords: Pain
Range of Motion
Flexion-Distraction Technique
Conventional Physical Therapy
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 68
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: subjective pain
timeFrame: through study completion, an average of 6 months
measure: range of motion
timeFrame: through study completion, an average of 6 months
measure: objective pain
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Functional capacity
timeFrame: through study completion, an average of 6 months
measure: Daily living activities
timeFrame: through study completion, an average of 6 months
Other outcomes:
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