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

Sponsor
Foundation University Islamabad (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05680506
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pain neuroscience education
  • Procedure: Standard Therapy
N/A

Detailed Description

Low back pain is currently considered to be the most common cause of disability.This is the single greatest cause of years lived with disability.When low back pain occurs the 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 treatmet 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 education of patients regarding neuroscience behind their chronic low back pain.

A randomized control trial will be conducted in Tariq Memorial Neuro Clinic Islambad using non-probability purposive sampling.Participants will be briefed regarding the study objectives, procedure, risks and benefits of treament, voluntary participation and right to withdraw.Written informed consent will be taken from all the participants before conducting the research.Details of exercise program will be explained to them.Patients wiith chronic low back pain will be reffered by neuro-physician.Screening will be done by using Keel Start Back screening tool.Then the selected participants will be randomized into 2 groups(experimental group and control group)via sealed envelope method. Participants will complete Numeric Rating Pain Scale(NRPS) for pain, Roland Morris Disability Questionnaire for disability measurement and Tampa Scale for kinesiophobia.All of these measurements will be taken at baseline and then after 4 weeks of intervention.

The treatment protocol of both groups is as follows:

Group 1(Control group):hot pack, TENS for 15 mins, mobilization at L4-L5 segment, stretchings and stabilization exercises (5 reps/1set) Group 2(Experimental group):Pain neuroscience education for 15 mins, hot pack, TENS,mobilization at L4-L5 segment, stretchings and stabilization exercises.(5 reps/1 set)

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Single (Outcomes Assessor)
Masking Description:
The outcome assessor will be a another person who will be unaware of the group the particpant belong to
Primary Purpose:
Treatment
Official Title:
Effects of Pain Neuroscience Education With Conventional Physical Therapy in Patients With Chronic Low Back Pain
Actual Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pain neuroscience education group

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

Procedure: Standard Therapy
Hot pack,TENS, Kaltenborn grade 1 and 2 mobilizations, stretchings and lumbar stabilization exercises

Active Comparator: Standard therapy group

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

Outcome Measures

Primary Outcome Measures

  1. Pain intensity [4 weeks]

    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

  2. Disability [4 weeks]

    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).

  3. Kinesiophobia [4 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Both male and female of age 40-65 years

  • Patients with chronic primary low back pain (medium risk patients on Start Back Screening Tool)

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Foundation University College of Physical Therapy Rawalpindi Punjab Pakistan 46000

Sponsors and Collaborators

  • Foundation University Islamabad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Foundation University Islamabad
ClinicalTrials.gov Identifier:
NCT05680506
Other Study ID Numbers:
  • FUI/CTR/2022/21
First Posted:
Jan 11, 2023
Last Update Posted:
Jan 11, 2023
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2023