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The Effect of Manual Therapy and Therapeutic Exercises on Pain and Functional Status in Persons With Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Manual therapy
Exercise therapy
Sponsored by
Lithuanian Sports University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, manual therapy, exercise therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Non-specific low back pain (>8 weeks); Persons of working age; Must be able to perform therapeutic exercises. Exclusion Criteria: Severe cardiovascular disease; Oncological disorders; Neurological symptoms of disorders; Osteoarthritis; Spondylolisthesis and spondylosis; Radiculopathy; Myelopathy; Spinal fracture. Pregnancy or lactation.

Sites / Locations

  • Lithuanian Sports University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Manual therapy

Exercise therapy

Arm Description

6 weeks, 12 sessions in total, 2 times a week of manual therapy: spinal manipulation, specific mobilisations and stretches. Manual therapy treatments are carried out by a physiotherapist with more than 10 years of experience. In addition, 6 weeks, 5 times a week, a programme of therapeutic exercises at home: muscle strengthening and stretching, balance and coordination training, spinal stabilisation exercises.

6 weeks, 12 sessions in total, 2 times a week therapeutic exercise programme under the supervision of a physiotherapist. The exercise programme consisted of muscle strengthening and stretching, balance and coordination training, spinal stabilisation exercises. In addition, 6 weeks, 5 times a week, a programme of therapeutic exercises at home: muscle strengthening and stretching, balance and coordination training, spinal stabilisation exercises.

Outcomes

Primary Outcome Measures

Change from baseline Pain at 6 weeks
Pain was assessed using a Numerical Rating Scale (NRS) that used a 10-cm line with end-point descriptors such as 'no pain' marked at the left end and 'worst pain imaginable' marked at the right end. Patients were asked to mark a point on the line that best represented their pain at the time of the evaluation. The distance from 'no pain' to the patient's mark was then measured and recorded as the NRS score: 0 cm was defined as no pain, 1-3 cm as mild pain, 4 or 5 cm as moderate pain, 6-8 cm as severe pain and 9 or 10 cm as the worst pain imaginable.
Change from baseline Oswestry Disability Index for functional status at 6 weeks
The Oswestry questionnaire (ODI) was used to assess the impact of back pain on functional status and disability. It consists of ten questions (pain intensity, self-care, lifting objects, walking, sitting, standing, sleeping, sexual life, social life and travelling). There are six answer options for each question, and the value of each question ranges from 0 (no problems/no disability) to 5 (major problems/major disability in this area). The total ODI score is calculated as the sum of the scores for each question and the total ODI score ranges from 0 to 50. The percentage of scores is calculated as follows: sum of scores / 50 x 100 = percentage (%). The lower the score, the lower the impact of pain on functional status.
Change from baseline Roland Morris Disability Questionnaire at 6 weeks
The Roland Morris Disability Questionnaire consists of 24 statements relating to daily living and physical activities such as personal care, sleep, work and walking. The scale ranges from 0 to 24, with the highest score indicating maximum functional disability.
Change from baseline Mobility of the lumbar spine at 6 weeks
The Schober test was used to assess lumbar spine mobility. The test is performed with the subject standing upright, arms at the sides, and the examiner locates the midline between the iliac crests, on the dorsal side, and marks the first point there. A second point is marked 10 cm above the first point. 5 cm below the first marked point, a third point shall be marked. The subject is then asked to bend forward as far as he or she can without pain and without bending the knees, and the distance between the first and the third point is measured with a centimetre tape. The test is negative if the distance between the marked points is 7 cm or more and positive if the distance is less than 7 cm, indicating limited mobility of the lumbar spine.
Change from baseline Abdominal muscle static endurance at 6 weeks
Static abdominal muscle endurance test - Kraus-Weber. The subject lies on the back, knees bent at 90 degrees, arms crossed over the chest. The subject flexes the thorax, i.e. pulls the lower shoulder blade away from the surface, and is isometrically holds the body in this position. The test is terminated if the subject remains in this position for more than 300 seconds. The test shall be terminated when the lower scapular angle descends downwards and is no longer maintained or when the subject experiences unpleasant sensations and/or pain.
Change from baseline Back muscle static endurance at 6 weeks
Static back muscle endurance test - Ito. The subject lies on his/her stomach, arms at his/her sides, palms up. The subject lifts the upper trunk to the lower sternum from the lying surface. The test is terminated if the subject remains standing for more than 300 seconds. If the subject does not maintain the position and touches the ground or experiences unpleasant sensations and/or pain, the test shall also be terminated.
Change from baseline Kinesiophobia at 6 weeks
The Tampa Scale of Kinesiophobia was used to assess the fear of movement or repetitive trauma in pain patients. The highest score indicates a high level of kinesiphobia.

Secondary Outcome Measures

Full Information

First Posted
February 24, 2023
Last Updated
March 14, 2023
Sponsor
Lithuanian Sports University
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1. Study Identification

Unique Protocol Identification Number
NCT05784168
Brief Title
The Effect of Manual Therapy and Therapeutic Exercises on Pain and Functional Status in Persons With Low Back Pain
Official Title
The Effect of Manual Therapy and Therapeutic Exercises on Pain and Functional Status in Persons With Chronic Non-specific Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lithuanian Sports University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Non-specific chronic low back pain (LBP) can be managed with a variety of treatments such as educational programmes, behavioural therapy, acupuncture, medication, electrophysical agents, manual therapy and exercise therapy. Although the above therapies are widely used, they show limited effect at best, with frequent recurrences of LBP. There is insufficient data to prove that one type of exercise is superior to another. Manual therapy is a common therapeutic method used in the treatment of LBP. Therefore, we hypothesised that manual therapy combined with therapeutic exercises would lead to a greater reduction in back pain and improvement in functional status. The aim of the study was to evaluate the effect of 6 weeks of manual therapy combined with therapeutic exercise on pain and functional status in subjects with chronic non-specific low back pain.
Detailed Description
The individuals with chronic non-specific low back pain participated in the study. Subjects were randomly divided into two groups: physiotherapy and manual therapy. All the participants received 12 intervention sessions. In addition, all subjects exercised at home 5 days a week. Subjects' back static strength endurance was assessed by the ITO test, abdominal muscle static strength endurance was assessed by the Kraus-Webber test, fear of movement by the TAMPA kinesiophobia test, torso mobility by the Schober test, pain by the numerical analogy scale. Functional status was assessed by Oswestry and Roland-Morris questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, manual therapy, exercise therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual therapy
Arm Type
Experimental
Arm Description
6 weeks, 12 sessions in total, 2 times a week of manual therapy: spinal manipulation, specific mobilisations and stretches. Manual therapy treatments are carried out by a physiotherapist with more than 10 years of experience. In addition, 6 weeks, 5 times a week, a programme of therapeutic exercises at home: muscle strengthening and stretching, balance and coordination training, spinal stabilisation exercises.
Arm Title
Exercise therapy
Arm Type
Experimental
Arm Description
6 weeks, 12 sessions in total, 2 times a week therapeutic exercise programme under the supervision of a physiotherapist. The exercise programme consisted of muscle strengthening and stretching, balance and coordination training, spinal stabilisation exercises. In addition, 6 weeks, 5 times a week, a programme of therapeutic exercises at home: muscle strengthening and stretching, balance and coordination training, spinal stabilisation exercises.
Intervention Type
Other
Intervention Name(s)
Manual therapy
Intervention Description
6 weeks, 12 sessions in total, 2 times a week of manual therapy: spinal manipulation, specific mobilisations and stretches. Manual therapy treatments are carried out by a physiotherapist with more than 10 years of experience. In addition, 6 weeks, 5 times a week, a programme of therapeutic exercises at home: muscle strengthening and stretching, balance and coordination training, spinal stabilisation exercises.
Intervention Type
Other
Intervention Name(s)
Exercise therapy
Intervention Description
6 weeks, 12 sessions in total, 2 times a week therapeutic exercise programme under the supervision of a physiotherapist. The exercise programme consisted of muscle strengthening and stretching, balance and coordination training, spinal stabilisation exercises. In addition, 6 weeks, 5 times a week, a programme of therapeutic exercises at home: muscle strengthening and stretching, balance and coordination training, spinal stabilisation exercises.
Primary Outcome Measure Information:
Title
Change from baseline Pain at 6 weeks
Description
Pain was assessed using a Numerical Rating Scale (NRS) that used a 10-cm line with end-point descriptors such as 'no pain' marked at the left end and 'worst pain imaginable' marked at the right end. Patients were asked to mark a point on the line that best represented their pain at the time of the evaluation. The distance from 'no pain' to the patient's mark was then measured and recorded as the NRS score: 0 cm was defined as no pain, 1-3 cm as mild pain, 4 or 5 cm as moderate pain, 6-8 cm as severe pain and 9 or 10 cm as the worst pain imaginable.
Time Frame
Baseline and after 6 weeks
Title
Change from baseline Oswestry Disability Index for functional status at 6 weeks
Description
The Oswestry questionnaire (ODI) was used to assess the impact of back pain on functional status and disability. It consists of ten questions (pain intensity, self-care, lifting objects, walking, sitting, standing, sleeping, sexual life, social life and travelling). There are six answer options for each question, and the value of each question ranges from 0 (no problems/no disability) to 5 (major problems/major disability in this area). The total ODI score is calculated as the sum of the scores for each question and the total ODI score ranges from 0 to 50. The percentage of scores is calculated as follows: sum of scores / 50 x 100 = percentage (%). The lower the score, the lower the impact of pain on functional status.
Time Frame
Baseline and after 6 weeks
Title
Change from baseline Roland Morris Disability Questionnaire at 6 weeks
Description
The Roland Morris Disability Questionnaire consists of 24 statements relating to daily living and physical activities such as personal care, sleep, work and walking. The scale ranges from 0 to 24, with the highest score indicating maximum functional disability.
Time Frame
Baseline and after 6 weeks
Title
Change from baseline Mobility of the lumbar spine at 6 weeks
Description
The Schober test was used to assess lumbar spine mobility. The test is performed with the subject standing upright, arms at the sides, and the examiner locates the midline between the iliac crests, on the dorsal side, and marks the first point there. A second point is marked 10 cm above the first point. 5 cm below the first marked point, a third point shall be marked. The subject is then asked to bend forward as far as he or she can without pain and without bending the knees, and the distance between the first and the third point is measured with a centimetre tape. The test is negative if the distance between the marked points is 7 cm or more and positive if the distance is less than 7 cm, indicating limited mobility of the lumbar spine.
Time Frame
Baseline and after 6 weeks
Title
Change from baseline Abdominal muscle static endurance at 6 weeks
Description
Static abdominal muscle endurance test - Kraus-Weber. The subject lies on the back, knees bent at 90 degrees, arms crossed over the chest. The subject flexes the thorax, i.e. pulls the lower shoulder blade away from the surface, and is isometrically holds the body in this position. The test is terminated if the subject remains in this position for more than 300 seconds. The test shall be terminated when the lower scapular angle descends downwards and is no longer maintained or when the subject experiences unpleasant sensations and/or pain.
Time Frame
Baseline and after 6 weeks
Title
Change from baseline Back muscle static endurance at 6 weeks
Description
Static back muscle endurance test - Ito. The subject lies on his/her stomach, arms at his/her sides, palms up. The subject lifts the upper trunk to the lower sternum from the lying surface. The test is terminated if the subject remains standing for more than 300 seconds. If the subject does not maintain the position and touches the ground or experiences unpleasant sensations and/or pain, the test shall also be terminated.
Time Frame
Baseline and after 6 weeks
Title
Change from baseline Kinesiophobia at 6 weeks
Description
The Tampa Scale of Kinesiophobia was used to assess the fear of movement or repetitive trauma in pain patients. The highest score indicates a high level of kinesiphobia.
Time Frame
Baseline and after 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-specific low back pain (>8 weeks); Persons of working age; Must be able to perform therapeutic exercises. Exclusion Criteria: Severe cardiovascular disease; Oncological disorders; Neurological symptoms of disorders; Osteoarthritis; Spondylolisthesis and spondylosis; Radiculopathy; Myelopathy; Spinal fracture. Pregnancy or lactation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vytautas Pilelis, Master
Organizational Affiliation
Lithuanian Sports University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lithuanian Sports University
City
Kaunas
Country
Lithuania

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Manual Therapy and Therapeutic Exercises on Pain and Functional Status in Persons With Low Back Pain

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