Flexion-Distraction Technique

NCT06886334 | Not Yet Recruiting Phase 1

• 1 other identifier: E-10840098-202.3.02-7694
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lumbar Disc Herniation

Keywords

Pain; Range of Motion; Flexion-Distraction Technique; Conventional Physical Therapy

Outcome Measures

Primary Outcomes (3)

• subjective pain

  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".

  through study completion, an average of 6 months

• range of motion

  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.

  through study completion, an average of 6 months

• objective pain

  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

  through study completion, an average of 6 months

Secondary Outcomes (2)

• Functional capacity

  through study completion, an average of 6 months

• Daily living activities

  through study completion, an average of 6 months

Study Arms (2)

Conventional Physical Therapy Group (CPTG)

ACTIVE COMPARATOR

A treatment protocol of ultrasound, TENS, hot pack, and exercises will be applied 3 times weekly for 4 weeks. Ultrasound (4 minutes per side) uses high-frequency waves for deep tissue healing. TENS (100 Hz, 20 minutes) delivers electrical currents to block pain signals. Hot packs (15 minutes) increase circulation and relax muscles. Exercises include Pelvic Tilt, Hip Flexor Stretch, Hamstring Stretch, Cat-Camel, Bridge, and Straight Leg Raise, aimed at improving flexibility, strength, and pain relief.

Other: exercise

Flexion-Distraction Group (Cox Technique) (CTG):

EXPERIMENTAL

n addition to hot packs (15 minutes) and exercises, the flexion-distraction (Cox) technique will be used for 10 minutes. Developed in 1973, this chiropractic method uses a specialized table to decompress the spine, improve mobility, and reduce pain. Exercises include Pelvic Tilt, Hip Flexor Stretch, Hamstring Stretch, Cat-Camel, Bridge, and Straight Leg Raise, targeting flexibility, strength, and pain relief. Hot packs increase circulation and relax muscles. Both treatments are applied 3 times weekly for 4 weeks, ensuring consistent therapeutic benefits.

Other: mobilization

Interventions

exercise OTHER

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.

Conventional Physical Therapy Group (CPTG)

mobilization OTHER

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.

Flexion-Distraction Group (Cox Technique) (CTG):

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

MeSH Terms

Conditions

Intervertebral Disc Displacement; Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

gulay yalcin

CONTACT

00905376342600; karacaoglugulay@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be assigned in a blinded manner based on their preferred treatment center. Each center will administer a specific treatment protocol: one center will apply the flexion-distraction technique (Cox technique), while the other will provide conventional physical therapy. Participants will receive the treatment corresponding to the center they choose, ensuring that the allocation is based on their preference while maintaining the integrity of the study design. This approach allows for a natural randomization process while minimizing bias, as participants are unaware of the differences in treatment protocols between the centers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Head of Physiotherapy and Rehabilitation Department

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 20, 2025
• Study Start: April 2, 2025
• Primary Completion: April 3, 2026
• Study Completion: May 1, 2026
• Last Updated: March 20, 2025

Record last verified: 2025-03