Effects of Patient Education Manual in Patient With Chronic Low Back Pain

October 26, 2020 updated by: Riphah International University

Effects of Patient Education Manual on Pain, Range of Motion and Function in Patient With Chronic Low Back Pain Neck Pain

It was a randomized clinical trial conducted to determine the effects of patient education manual on pain, range of motion and function in patient with chronic low back pain at Salamat hospital Satellite Town Gujranwala in patients with 6-month chronic low back pain who were willing to follow patient education manual. Patients were assessed for pain, disability due to backpain and lumbar ranges, at baseline, 2nd, 4th and 6th week of intervention. The SPSS 20.0 version was used to analyse data. Tests of normality were executed that whether data was normative or non-parametric, based on which outcomes were compared either using independent samples t test or Mann-Whitney test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of current study was to figure out how patient education manual can impact the outcomes, such as decreasing pain and disability and increasing range of lumbar spine, in patients having low back pain. The patient education manual model has been under research in recent time all over the world. There have been mixed results. Mostly there is moderate to high quality evidence in support of patient education that it can help improving the efficacy of physical therapy treatment. However, the previous literature lacks in uniformity of outcome measures used in the studies and spinal ranges have not been studied in majority studies.

This study was conducted by developing a patient education manual given to patients along with routine physical therapy. The study findings showed that the patients with combination of patient education manual and routine physical therapy improved their disability level significantly more than the patients in control group receiving routine physical therapy alone. However, there was no significant difference in improvement of pain itself and spinal ranges of lumbar region except lumbar flexion which was improved significantly among patient education manual group. When the analysis was performed for within group pre and post interventional difference in both groups separately, it was seen that patient improved in both groups significantly at all stages of measurements such as 2nd, 3rd and 6th week, p value less than 0.05.

Looking closer, it was seen that pain was improving similarly in both groups, p value more than 0.05. However, it was slightly better in Group A, having combination of patient education manual and routine physical therapy, with a slight mean difference i.e. -.33333 at 2nd and 4th week and -.41667 at 6th week post intervention. In past studies pain has been reported to be significantly better with patient education groups.

The disability was measured by Oswestry Disability Index for back pain. It was seen that patients having patient education manual significantly improved at all assessment stages i.e. at 2nd, 4th and 6th week, p value less than 0.05. This was the only outcome in this study showing a significantly better effect of patient education manual with straight and clear findings. The mean difference was of 4.25000 at 2nd week, while peak mean difference of 8.83333 points was seen at 4th week which declined to 4.83333 at 6th week but it was still significantly better as compared to routine physical therapy group. It also indicated the gradually fading off difference in long term assessment. In previous studies functional has always been found to improve with patient education. This might due to nature of this outcome which is based on patients' experience and perception, which means due to patient education or information material, it is possible that it has uplifted moral of patients and ultimately, they feel better in all aspects of function. Whatsoever the reason, disability can be greatly improved by use of patient education method in patient with low back pain.

The spinal ranges was the special outcome measure in current study that has been addressed the least in previous literature. It was seen that except lumbar flexion, all ranges were improving without any significant difference, even the improvement in lumbar flexion became same at 6th week assessment. Moreover, there was no consistency in mean difference of ranges, some ranges improved slightly better at one stage of assessment while the same ranges were slightly less improved at other stage, but overall there was no significant difference.

A study had discussed effect of patient education on ranges in terms of its long-term impact and recurrence of hypomobility in spinal region. The study has multiple outcome measures such as pain, disability, ranges and quality of life. The study suggested that all in short term patient education played a significantly better role in improving pain, function and life quality but ranges were no different. Furthermore, all ranges were not measured due to their consistently being similar.

It can be said that all outcomes in which were clinician-based has no difference of improvement in patient education manual group or that of control group while the outcome which were based on patient's perception were improved more among patient education manual group. This pattern can be seen in satisfaction with manual therapy. Although, satisfaction was not associated with treatment group as shown by non-significant p value of chi square more than 0.05, but it can be seen that patients with patient education manual reported themselves to be 'very satisfied' category while in control group the majority patients reported themselves in 'satisfied' category. This showed that all patients were satisfied with care provided for treatment of backpain but providing a patient education manual can further boost their satisfaction which is then reflected in their function.

In short, the outcomes such as function were improved with combination of patient education manual and routine physical therapy while the pain and ranges were no different with or without patient education manual. There needs further studies with more sample size and long term assessment in order see long term impact of patient education manual.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Gujrānwāla, Punjab, Pakistan
        • Salamat Hospital,Satellite Town

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 6 months chronic,
  • localized low back pain

Exclusion Criteria:

  • Patients with radicular low back pain
  • Ankylosing spondylitis
  • spinal stenosis
  • Fibromyalgia
  • 0steoprosis
  • Cognitive impairment
  • Traumatic injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical therapy with Patient education
Treated with proper physical therapy treatment protocol according to patient presenting condition and patient education manual
Other: Physical therapy with Patient education
patient manual was translated and validated in Urdu which was provided to patients so that they can follow it at home
Other Names:
  • patient education manual
Experimental: Physical Therapy without patient Education
Treated with proper physical therapy treatment protocol according to patient presenting condition
Other: Physical Therapy without patient Education
Group B was only treated with proper physical therapy treatment protocol according to patient presenting condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index
Time Frame: 6th Week
The Oswestry Disability Index (ODI) (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tool. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible
6th Week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale (NPRS)
Time Frame: 6th Week
NPRS is anchored by terms describing pain severity extremes. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
6th Week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
GONIOMETER
Time Frame: 6th Week
A goniometer is a device used in physical therapy to measure the range of motion around a joint in the body. We will use this to measure range of motions ROM on spine, Flexion, Extension, Rotation, Sideflexion R & L
6th Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Syed Shakil Ur-Rehman, PhD, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2019

Primary Completion (Actual)

August 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

October 19, 2020

First Submitted That Met QC Criteria

October 19, 2020

First Posted (Actual)

October 23, 2020

Study Record Updates

Last Update Posted (Actual)

October 28, 2020

Last Update Submitted That Met QC Criteria

October 26, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCRS/20/1003 Mubashra

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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