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A study to investigate the effectiveness of mechanical traction in treating people with lower back pain and sciatica caused by a herniated lumbar disc

The effects of pre-operative mechanical traction for patients with a confirmed diagnosis of disc herniation awaiting discectomy on pain and sciatic nerve biomechanics

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15050704
Enrollment
102
Registered
2018-06-26
Start date
2018-06-01
Completion date
Unknown
Last updated
2020-02-24

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

Conditions

Lumbar disc herniation Musculoskeletal Diseases

Interventions

All patients will be randomly placed in a group to receive traction or continue with their pre-existing treatment. All patients will be assessed by a Chartered Physiotherapist and if they are in a tra

Sponsors

Plymouth Marjon University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients aged between 18 and 60 years (both inclusive) 2. Diagnosis of a single level unilateral lumbar disc protrusion causing the appropriate nerve root impingement (within 6 months of diagnosis) 3. Decision to operate has been made and patient awaiting surgery 4. Patients who have residual leg pain as defined by a positive straight leg raise (SLR) sign (specified as less than 66° movement of the straight leg relative to the longitudinal axis of the trunk that the test reproduced unilateral symptoms in the tested leg)

Exclusion criteria

Exclusion criteria: 1. Presence of the following red flag features – bladder/bowel dysfunction, history of cancer, thoracic night pain, previous history of lumbar surgery, saddle anaesthesia 2. Significant cardio-respiratory disorder 3. Pregnancy 4. Weight more than 20% of ideal norms for height and age or more than 140 kg

Design outcomes

Primary

MeasureTime frame
Pain rating on a Numerical Pain Score. Participants will be asked to rate their severity of leg pain using a simple numerical Pain Score (Jensen et al.,1996), with a minimal clinically important difference (MICD) of 2.0 (Dworkin et al., 2005), measured at baseline, end of trial (1 month), and 6 months

Secondary

MeasureTime frame
1. The improvement will be measured with the Global Rating of Change Scale before and after the intervention (Dworkin et al., 2005) with a 15 point scale (-7 to +7), with a clinically important improvement defined as 5 or more (Stratford et al., 1994), measured at end of trial (1 month) and 6 months 2. Functional ability will be measured using the Oswestry Disability Index questionnaire; a valid and reliable disease-specific patient completed questionnaire of function (Fairbank and Pynsent, 2000), with a minimum clinically important difference of 12.8 (Copay et al., 2008), measured at baseline, end of trial (1 month), and 6 months 3. Medication: Type and dosage of medication that each participant is currently taking will be recorded and retrieved from patients’ record by the research physiotherapist, measured at baseline, end of trial (1 month), and 6 months 4. Clinical examinations: Routine clinical tests including range of motion tests, straight leg raise test, neurological tests including reflex, ankle clonus, Babinski, dermatomes, and myotomes test will be included and carried out by the blinded research physiotherapist before and post intervention. A standardized passive straight leg raise test will be performed and the maximum angle between the straight leg and the longitudinal axis of the trunk will be measured using an inclinometer. Straight leg raise sign will be considered to be positive if the lift angle is less than 66°, with unilateral symptoms reproduced in the tested leg (Rebain et al., 2002, Tafazzoli and Lamontagne, 1996). Measured at baseline, end of trial (1 month), and 6 months 5. Sciatic/tibial nerve movement and spine and hip kinematics: Ultrasound recording (linear arrays centre frequency 7.5Mhz) during forward, backward and sideways bending will be taken at popliteal fossa of the knee in order to track the movement of the tibial nerve (Shum et al., 2013, Shum et al., 2015). This

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026