Effects of Pain Neuroscience Education With Conventional Physical Therapy in Patients With Chronic Low Back Pain

NCT05680506 | Unknown

• 1 other identifier: FUI/CTR/2022/21
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain is currently considered to be the most common cause of disability.When low back pain occurs sensitivity of body increases which decreases overall body activity.Physical inactivity negatively effects recovery from chronic low back pain.Patients with chronic low back pain experience psychological anxiety and depression which leads to fear of pain and movement.There are various treatment options for chronic low back pain.But most treatment options deal with biomedical aspect of disease.Pain neuroscience education deals with psychological aspect of disease.By combining both treatment options we will be able to evaluate the combined biopsychosocial aspect of treatment.This study will mainly focus on the education of patients regarding neuroscience be hind their chronic low back pain.

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (3)

• Pain intensity

  Pain intensity will be measured on numeric rating pain scale. It consists of 11 points( interval 0-10), where 0 corresponds to no pain and 10 corresponds to worst pain imaginable. A graphical representation of 11 spaces is used for patients own evaluation of his or her pain

  4 weeks

• Disability

  The activity disorder index is assessed using the Roland Morris Disability Questionnaire RMDQ. It consists of 0-24 point scale. The score ranges from 0 (no disability) to 24 (maximum disability).

  4 weeks

• Kinesiophobia

  Tampa scale is used in patients with chronic musculoskeletal pain.It composed of 17 items scoring range from 1-4: (1) strongly disagree, (2) disagree, (3) agree,(4) strongly agree. For items 4,8,12 and 6 its vice versa.The total score of scale range from 17-68, where 17 means no kinesiophobia, 68 means severe kinesiophobia and 37 means there is kinesiophobia.

  4 weeks

Study Arms (2)

Pain neuroscience education group

EXPERIMENTAL

Pain neuroscience education 10- 15min Hot pack(10 min) TENS Kaltenborn Moilization technique at L4-L5 segment stretchings and stabilization exercises. (5 reps/1 set) Total duration:40 min/session

Procedure: Pain neuroscience education; Procedure: Standard Therapy

Standard therapy group

ACTIVE COMPARATOR

Hot pack(10 min) TENS Kaltenborn Mobilization technique at L4-L5 segment stretchings and stabilization exercises (5 reps /1 set) Total duration:30 min/session

Procedure: Standard Therapy

Interventions

Pain neuroscience education PROCEDURE

Pain neuroscience education will be given in form videos,pictures, stories and metaphors for 2 times per week for 4 weeks.

Pain neuroscience education group

Standard Therapy PROCEDURE

Hot pack,TENS, Kaltenborn grade 1 and 2 mobilizations, stretchings and lumbar stabilization exercises

Pain neuroscience education group; Standard therapy group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both male and female of age 40-65 years
• Patients with chronic primary low back pain (medium risk patients on Start Back Screening Tool)

You may not qualify if:

• patients with motor and sensory dysfunction
• patients with neurological abnormalities and muscle paalysis
• patients with dizziness and uncontrolled hypertension
• patients who could not take the basic posture of lumbar stabilization exercises because of pain

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be a another person who will be unaware of the group the particpant belong to
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a randomized controlled trial which will consist of two groups. One will recieve conventional physcial therapy only and the second will recieve conventional physcial therapy with pain neuroscience education.Both groups will be recruited concurrently.

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: January 11, 2023
• Study Start: August 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: February 1, 2023
• Last Updated: January 11, 2023

Record last verified: 2022-12

Locations

PA (1)