Management of LBP With Radiculopathy.

NCT04022798 | Unknown DMC

• 1 other identifier: UTabuk
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to determine the effectiveness of Neural mobilization(NM) technique compared with lumbar stabilization exercise (LSE) and Radial Extracorporeal Shock Wave Therapy (rESWT) in the physical therapy management of chronic low back pain (CLBP) with radiculopathy. Subjects will be randomly assigned into two groups. Group A (NM, LSE and rESWT) and Group B (LSE and rESWT).

Conditions

Low Back Pain

Keywords

Low back pain; Neural mobilization; lumbar stabilization exercise; Radial extracorporeal shock wave therapy

Outcome Measures

Primary Outcomes (3)

• Change in Pain is being assessed using NPRS

  Pain was assessed by using NPRS, where 0 represented no pain and 10 represented the worst pain possible, to indicate the intensity of pain in the lower back (Jensen et al., 1994).

  baseline, 3 weeks and 6 weeks

• Change in Disability is being assessed using the Modified Oswestry Disability Questionnaire

  Disability was measured by using the Modified Oswestry Disability Questionnaire (MODQ) which is a self-rating questionnaire used to evaluate functional physical disability (Rajfur, et al., 2017).

  baseline, 3 weeks and 6 weeks

• Change in Lumbar flexion range of motion is being assessed using modified Schober method

  Lumbar flexion range of motion was measured by using modified Schober method (Philadelphia Panel Members, 2001).

  baseline, 3 weeks and 6 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Neural mobilization (NM), lumbar stabilization exercise (LSE) and Radial Extracorporeal Shock Wave Therapy (rESWT)

Other: Exercise, manual therapy

Control group

ACTIVE COMPARATOR

lumbar stabilization exercise (LSE) and Radial Extracorporeal Shock Wave Therapy (rESWT)

Other: Exercise, manual therapy

Interventions

Exercise, manual therapy OTHER

Participants were randomly assigned into treatment (n=15) or control group (n=15). Participants in each group received 12 treatment sessions of 45 minutes each, 2 days a week for 6 consecutive weeks. For each group, a menu of a lumbar stabilization program was designed. This program included 8 levels of exercise ( single leg knee to chest stretch, double leg knee to chest, supine piriformis stretch, supine hamstring stretch, lower trunk rotation stretch, lumbar rotation stretch, pelvic tilt, pelivic tilt with alternative legs). Exercises were tailored for each individual ability and, if possible, progressed at each session which would last approximately 30 minutes. Each single exercise was repeated many times based on the patient's clinical condition. All sessions were provided by physiotherapists.

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lower back pain should be Lower than 5 on the Visual Analogue Scale,
• \> 18 years,
• Not taken physical therapy treatment in the past 6 months period,
• No previous surgery, such as structural anomalies, spinal cord compressions, severe instabilities, severe osteoporosis, acute infections, severe cardiovascular or metabolic diseases,
• A body mass index less than 30kg/m2.

You may not qualify if:

• Pain with a score above 5 on the Visual Analogue Scale (VAS),
• ≤ 18 years,
• Had physical therapy treatment in the past 6 months period,
• Had undergone previous surgery, such as structural anomalies, spinal cord compressions, severe instabilities, severe osteoporosis, acute infections, severe cardiovascular or metabolic diseases,
• pregnant
• A body mass index above 30kg/m2.

Sponsors & Collaborators

• University of Tabuk: lead

Study Sites (1)

Salem F Alatawi

Tabuk, 71491, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Salem F Alatawi, PhD

  University of Tabuk

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salem F Alatawi, PhD

CONTACT

0549638301; sfalatawi@ut.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Experimental group: Group A (NM, LSE and rESWT) and Control group: Group B (LSE and rESWT).

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 17, 2019
• Study Start: July 1, 2019
• Primary Completion: October 30, 2019
• Study Completion: November 30, 2019
• Last Updated: July 17, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)