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Impact of non-surgical spinal decompression therapy on disc morphology, pain, and disability in lumbar radiculopathy: A Randomised controlled trial

Impact of non-surgical spinal decompression therapy on disc morphology, pain, and disability in lumbar radiculopathy: A Randomised controlled trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000367347
Enrollment
60
Registered
2026-03-24
Start date
2026-04-06
Completion date
2026-07-21
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Lumbar intervertebral disc herniation (LDH) is a leading cause of low back pain and radiculopathy, affecting a large proportion of the adult population and often resulting in significant functional limitations and reduced quality of life. Conservative management remains the first-line treatment for LDH, with goals to reduce pain, improve function, and avoid surgery. Spinal traction has long been used as a non-invasive intervention aimed at reducing mechanical compression of the affected nerve roots by applying longitudinal distraction forces to the lumbar spine. Despite its widespread use, evidence regarding its clinical effectiveness and impact on disc morphology remains inconsistent. Spinal decompression therapy, utilizing computer-controlled, intermittent distraction, has emerged as an alternative technique. It aims to create negative intradiscal pressure to facilitate retraction of herniated disc material and promote disc hydration and healing. Preliminary studies suggest spinal decompression may provide greater pain relief and functional improvements; however, there is a shortage of available literature regarding its effects on herniated disc Morphology, pain intensity and patient disability in patients with lumbar radiculopathy due to herniated lumbosacral disc lesions. This study aims ti investigates the impact of the spinal decompression on disc morphology, pain intensity, and functional level in patients with LDH

Interventions

The traditional physiotherapy protocol consists of several modalities applied sequentially within the same treatment session. Each session begins with the application of hot moist heat at a temperature of 40–45°C for 15 minutes to promote tissue relaxation and increase blood flow. This is followed by Transcutaneous Electrical Nerve Stimulation (TENS) using a conventional mode. Conventional TENS is applied at a frequency of 80–100 Hz, with a pulse duration of 50–100 microseconds, in continuous m

The traditional physiotherapy protocol consists of several modalities applied sequentially within the same treatment session. Each session begins with the application of hot moist heat at a temperature of 40–45°C for 15 minutes to promote tissue relaxation and increase blood flow. This is followed by Transcutaneous Electrical Nerve Stimulation (TENS) using a conventional mode. Conventional TENS is applied at a frequency of 80–100 Hz, with a pulse duration of 50–100 microseconds, in continuous mode. The intensity is set at a sensory level without eliciting muscle contraction. Electrodes are placed paraspinally at the affected lumbar level, and the treatment is delivered for 15 minutes. The primary purpose of this modality is pain modulation through the gate control mechanism. Ultrasound therapy is then applied to the lumbar paraspinal muscles using a frequency of 1 MHz in continuous mode, with an intensity of 0.9 W/cm² for 7 minutes, utilizing a 4 cm² applicator head. This intervention is intended to increase tissue temperature and reduce muscle spasm. In the experimental group, spinal decompression therapy is additionally administered using the SpineMED decompression system for 30 minutes. The applied traction force ranges between 10–15% of the patient’s body weight. All modalities are delivered consecutively within the same session and not simultaneously. In the control group, the sequence of interventions is hot moist heat, followed by TENS, and then ultrasound. In the experimental group, the same sequence is followed, with the addition of spinal decompression therapy at the end of the session. All patients receive five treatment sessions per week, totaling 20 sessions over a period of four weeks. Adherence to the intervention is monitored through session attendance and systematic recording within the treatment system.

Sponsors

Emirates Health Services
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

• Adults aged 18–50 years. • MRI-confirmed lumbosacral herniated intervertebral disc. • Symptoms of lower back pain and radiculopathy. • Willingness to undergo nonsurgical spinal decompression therapy (NSDT) and follow study protocols.

Exclusion criteria

• Prior spinal surgery. • Severe neurological deficits requiring immediate surgery. • Severe osteoporosis, infection, malignancy, or spinal fractures. • Pregnancy.

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 4, 2026