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Completed

NCT Number: NCT07037641

Comparison of the Effectiveness of Chiropractic Manipulation Applied to the Lumbar Sacroiliac Region in Patients With Lumbar Disc Herniation

This study aims to compare the effectiveness of chiropractic manipulation applied to the lumbar and sacroiliac regions in patients with lumbar disc herniation. A total of 45 participants are randomly assigned into three groups (15 per group). The control group (CG) receives conventional physiotherapy, including hot pack, TENS, ultrasound, and exercise. The lumbar group (LG) receives the same physiotherapy program combined with lumbar spinal manipulation. The sacroiliac group (SIG) receives conventional physiotherapy combined with sacroiliac joint manipulation. Outcomes are measured using the Numeric Pain Rating Scale (NPRS), Quebec Back Pain Disability Scale, Tampa Scale for Kinesiophobia, and range of motion (ROM) assessments.

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Key information

Conditions

Spinal Manipulation Chiropractic Lumbal Disc Herniation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sinop University

Sinop, Turkey (Türkiye)

About this study

This randomized controlled trial investigates the comparative effectiveness of regional chiropractic manipulation in patients diagnosed with lumbar disc herniation. The study includes three groups, each consisting of 15 participants. All groups receive a standard physiotherapy protocol, including hot pack application, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, and exercise therapy.

The Control Group (CG) receives only the standard physiotherapy program. The Lumbar Group (LG) receives standard physiotherapy in combination with lumbar spinal manipulation.

The Sacroiliac Group (SIG) receives standard physiotherapy in combination with sacroiliac joint manipulation.

Interventions are delivered by licensed practitioners following standardized protocols. The study aims to evaluate the effects of region-specific chiropractic manipulations on pain intensity, functional disability, kinesiophobia, and lumbar range of motion. Assessments are conducted at baseline and at the end of the treatment period using validated measurement tools: the Numeric Pain Rating Scale (NPRS), Quebec Back Pain Disability Scale, Tampa Scale for Kinesiophobia, and goniometric range of motion measurements.

By comparing outcomes across these three groups, the study seeks to identify whether regionally targeted chiropractic manipulation enhances the clinical efficacy of conventional physiotherapy in managing lumbar disc herniation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be between the ages of 18 and 65
  • Have been diagnosed with lumbar disc herniation
  • Have signed the voluntary consent form

Exclusion criteria

  • Having a value below 4 according to the NAS
  • Having a contraindication to chiropractic manipulation
  • Having a rheumatic disease
  • Having undergone surgery in the lumbar and sacroiliac regions
  • Being pregnant or suspected of being pregnant
  • Having a malignant disease
  • Having severe physical and psychological disorders
  • Having acute fractures of the spine and lower extremities fractures in the lower extremities
  • Individuals with neurological and orthopedic deficits in the lower extremities

Treatment and study plan

Lumbar Spine Manipulation

Other

Painful lumbar segments will be identified through palpation of the spinous and transverse processes. Patients will be positioned side-lying with head supported by a pillow. The lower arm will rest across the chest, and the lower leg will be extended while the upper leg will be flexed, with the foot placed in the popliteal space. The practitioner will assume a 45-degree angled stance, stabilizing the patient's pelvis between their thighs. The hypothenar eminence will contact the mammillary process of the dysfunctional vertebra, while the opposite hand stabilizes the upper shoulder. A high-velocity, low-amplitude (HVLA) thrust will be applied in a rotational direction toward the patient's umbilicus. This technique will be performed twice per week for two weeks (4 sessions total), alongside conventional physiotherapy (hot pack, TENS, ultrasound, and exercise).

Sacroiliac Joint Manipulation

Other

The side for sacroiliac joint manipulation will be determined using the Derifield leg length test. Based on functional leg length differences, a PI (posterior-inferior) ilium will be identified. Patients will be positioned side-lying with appropriate limb and trunk alignment. The practitioner's hypothenar eminence will be placed on the PSIS of the dysfunctional side. A high-velocity, low-amplitude (HVLA) thrust will be applied in a rotational direction from the PSIS toward the patient's umbilicus to correct the joint dysfunction. The manipulation will be performed twice a week over two weeks (4 sessions in total), combined with conventional physiotherapy (hot pack, TENS, ultrasound, and exercise).

Conventional Physiotherapy

Other

Conventional physiotherapy will consist of hot pack, TENS, therapeutic ultrasound, and supervised exercises applied over two weeks (6 sessions/week). Hot packs filled with silicate gel will be wrapped in four towel layers and applied for 20 minutes with the patient prone and a pillow under the abdomen. TENS will be delivered via Chattanooga Intelect device with a symmetrical biphasic program for 30 minutes using four electrodes placed on the treatment area. Ultrasound will be applied continuously for 3 minutes with the same device. Patients will be instructed on lumbar mobility and strengthening exercises, performed twice daily with 15 repetitions each. No spinal or sacroiliac manipulation will be performed in this group.

Primary outcomes

  1. Pain Intensity (Numeric Pain Rating Scale - NPRS / NRS)

    Time frame: Baseline and at the end of 2 weeks

    Pain intensity will be assessed using the Numeric Pain Rating Scale (0-10), where higher scores indicate more severe pain.

  2. Functional Disability (Quebec Back Pain Disability Scale)

    Time frame: Baseline and at the end of 2 weeks

    Functional disability due to low back pain will be measured using the Quebec Back Pain Disability Scale. Higher scores indicate greater disability.

Secondary outcomes

  1. Kinesiophobia (Tampa Scale of Kinesiophobia - TSK)

    Time frame: Baseline and at the end of 2 weeks

    The Tampa Scale of Kinesiophobia will be used to assess fear of movement or re-injury. Higher scores indicate more severe kinesiophobia.

  2. Lumbar Range of Motion (ROM) Measurements

    Time frame: Baseline and at the end of 2 weeks

    Lumbar flexion, extension, lateral flexion, and rotation will be measured using a goniometer to evaluate changes in spinal mobility.

Sponsors and collaborators

Lead sponsor

SEFA HAKTAN HATIK

Other

Registry information

Acronym: CLuSH

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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