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

S

SEFA HAKTAN HATIK

Status

Completed

Conditions

Spinal Manipulation
Lumbal Disc Herniation
Chiropractic

Treatments

Other: Conventional Physiotherapy
Other: Sacroiliac Joint Manipulation
Other: Lumbar Spine Manipulation

Study type

Interventional

Funder types

Other

Identifiers

NCT07037641
CMT0008

Details and patient eligibility

About

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.

Full description

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.

Enrollment

45 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

45 participants in 3 patient groups

Lumbar Region Group (LBG)
Experimental group
Description:
Participants in the lumbar manipulation group will receive the same conventional physiotherapy program as the control group (hot pack, TENS, ultrasound, and exercise therapy), along with high-velocity low-amplitude (HVLA) chiropractic manipulation applied specifically to the lumbar spine. The lumbar manipulation will be administered twice per week, totaling four sessions over a two-week period.
Treatment:
Other: Lumbar Spine Manipulation
Sacroiliac Joint Manipulation Group (SEG)
Experimental group
Description:
Participants in the sacroiliac joint manipulation group will receive the standard physiotherapy protocol (hot pack, TENS, ultrasound, and exercise therapy) in combination with high-velocity low-amplitude (HVLA) chiropractic manipulation targeted at the sacroiliac (SI) joint. The SI joint manipulation will be performed twice weekly, for a total of four sessions over two weeks.
Treatment:
Other: Sacroiliac Joint Manipulation
Control Group (CG)
Active Comparator group
Description:
Participants in the control group will receive conventional physiotherapy consisting of hot pack application, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, and supervised exercise therapy. These treatments will be applied regularly over a two-week period. No chiropractic or manual therapy will be administered in this group.
Treatment:
Other: Conventional Physiotherapy

Trial contacts and locations

1

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Central trial contact

SEFA H HATIK, Asst. Prof.; ÖMER D KIZIL, PhD.

Data sourced from clinicaltrials.gov

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