Low Back PainNCT05784168
The Effect of Manual Therapy and Therapeutic Exercises on Pain and Functional Status in Persons With Low Back Pain
A study testing Manual therapy and Exercise therapy in people with Low Back Pain, run by Lithuanian Sports University at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Manual therapy and Exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Jul 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-specific low back pain (>8 weeks);
- Persons of working age;
- Must be able to perform therapeutic exercises.
Who cannot join
- Severe cardiovascular disease;
- Oncological disorders;
- Neurological symptoms of disorders;
- Osteoarthritis;
- Spondylolisthesis and spondylosis;
- Radiculopathy;
Show all 9Show fewer
- Myelopathy;
- Spinal fracture.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Manual Therapy and Therapeutic Exercises on Pain and Functional Status in Persons With Chronic Non-specific Low Back Pain
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Manual therapy, Exercise therapy
- Keywords
- low back pain, manual therapy, exercise therapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyOther
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.
Exercise therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy | Experimental | 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. Receives: Other: Manual therapy |
| Exercise therapy | Experimental | 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. Receives: Other: Exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after 6 weeks
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.
Measured: Baseline and after 6 weeks
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.
Measured: Baseline and after 6 weeks
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.
Measured: Baseline and after 6 weeks
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.
Measured: Baseline and after 6 weeks
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.
Measured: Baseline and after 6 weeks
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.
Measured: Baseline and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Jul 2022
- Primary completion1 Nov 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian Sports University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vytautas Pilelis, Master, Principal investigator, Lithuanian Sports University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784168
- Sponsor's protocol ID
- LithuanianSportsU12
- Status last verified
- Mar 2023
- First submitted
- 24 Feb 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Manual Therapy and Therapeutic Exercises on Pain and Functional Status in Persons With Chronic Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT05784168
- Acronym / sponsor ID
- LithuanianSportsU12
- Conditions
- Low Back Pain
- Keywords
- low back pain, manual therapy, exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lithuanian Sports UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy | Experimental | Other: Manual therapy6 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. |
| Exercise therapy | Experimental | Other: Exercise therapy6 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-specific low back pain (>8 weeks);
- Persons of working age;
- Must be able to perform therapeutic exercises.
Key exclusion criteria (9 listed)
- Severe cardiovascular disease;
- Oncological disorders;
- Neurological symptoms of disorders;
- Osteoarthritis;
- Spondylolisthesis and spondylosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual therapy6 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. | Other | Manual therapy |
| Exercise therapy6 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. | Other | Exercise therapy |
Primary outcome
Change from baseline Pain at 6 weeks
Time frame: Baseline and after 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
Time frame: Baseline and after 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
Time frame: Baseline and after 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
Time frame: Baseline and after 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
Time frame: Baseline and after 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
Time frame: Baseline and after 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
Time frame: Baseline and after 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vytautas Pilelis, Master principal investigator
Lithuanian Sports University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy and Exercise therapy in people with Low Back Pain, run by Lithuanian Sports University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Pain at 6 weeks (time frame: Baseline and after 6 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.