Back PainNCT03733964
The Effectiveness of Manual Therapy and PNF Compared With Kinesiotherapy in the Treatment of Non-specific Low Back Pain
A study testing Manual therapy, PNF and Manual therapy + PNF in people with Back Pain, run by Medical University of Lublin at 1 site in Poland.
Trial summary
The aim of the study was to determine whether the use of combination therapy consisting of manual therapy and proprioceptive neuromuscular facilitation (PNF) is more effective than the use of the techniques of manual therapy, PNF method or traditional physiotherapy as single methods in the treatment of non-specific… Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Back Pain
- What is being tested?
- Manual therapy, PNF and Manual therapy + PNF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2014to 30 Apr 2016
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- the patients' age between 25 and 55,
- symptomatic spinal disc herniation of the lumbar spine at levels L4-L5 and/or L5-S1,
- confirmed by imaging examinations (MR, TK),
- the patients' lack of use of non-steroid anti-inflammatory medications (NSAID) for a period of at least one week before the start of the tests.
Who cannot join
- people with cancer,
- past spinal injuries with damage to anatomical structures and osteoporosis,
- patients with a severe inflammatory condition (sciatica) and a massive hernia of the intervertebral disc which required surgical treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Manual Therapy and Proprioceptive Neuromuscular Facilitation (PNF) Compared With Traditional Kinesiotherapy in the Treatment of Non-Specific Low Back Pain
The aim of the study was to determine whether the use of combination therapy consisting of manual therapy and proprioceptive neuromuscular facilitation (PNF) is more effective than the use of the techniques of manual therapy, PNF method or traditional physiotherapy as single methods in the treatment of non-specific low back pain.
The study was designed as single-blinded Randomized Controlled Trial (RCT) and conducted on a group of 200 patients of Hospital in Parczew. The patients were randomly divided into four 50-person groups: A used manual therapy, B - PNF, C - manual therapy and PNF, and D -kinesiotherapy. Pain intensity was measured using VAS and Laitinen's questionnaire. Functional disability was assessed using Oswestry Disability Index (ODI) and Back Pain Functional Scale (BPFS).
Read more
. The hypotheses were:
- The greatest reduction of pain is observed in the combined therapy group consisting of manual therapy and PNF method
- The range of movement of the lumbar spine is the most improved in the combination therapy group consisting of manual therapy and PNF method.
- Neurological symptoms assessed by neurodynamic tests are reduced to the greatest extent in the combined therapy group consisting of manual therapy and PNF method.
- The degree of disability due to back pain as assessed using the Oswestry Disability Index (ODI) decreases in all study groups.
- The functioning of patients in everyday life assessed using Back Pain Functional Scale (BPFS) shows the biggest improvement in the combination therapy group consisting of manual therapy and PNF method.
Read the detailed description
The research was conducted upon acquiring an approval of the Bioethical Commission of the Medical University in Lublin, no. KE-0254/14/2014.
The patients were qualified for physiotherapeutic treatment by a physician working in the given centre - a specialist on medical rehabilitation or balneotherapy and physical medicine. None of the physicians were personally involved in the preparation and the manner of performing the test. Before commencing the tests, each patient was familiarised with their course, expressed their informed written consent for participation and random assignment to a specified tested group.
The following selection criteria were used for the groups: the patients' age between 25 and 55, symptomatic spinal disc herniation of the lumbar spine at levels L4-L5 and/or L5-S1, confirmed by imaging examinations (MR, TK), and the patients' lack of use of non-steroid anti-inflammatory medications (NSAID) for a period of at least one week before the start of the tests. People with cancer, past spinal injuries with damage to anatomical structures and osteoporosis were excluded from the tests. Patients who did not qualify also included those with a severe inflammatory condition (sciatica) and a massive hernia of the intervertebral disc which required surgical treatment.
The patients were randomly divided into four groups of 50 people: the manual therapy group (A), the PNF method group (B), the manual therapy and the PNF method group (C), as well as the traditional kinesiotherapy group (D).
The analgesic effectiveness of the used treatment was evaluated by means of the commonly used 10-point visual analogue scale of pain (VAS), the modified Laitinen questionnaire of pain indicators and Stratford's back pain functional scale (BPFS).
The functional evaluation involved a goniometric examination of active movements in the thoracic-lumbar spine.
Measurements of pain intensity using visual analogue pain scale (VAS) and a modified Laitinen's pain questionnaire were carried out four times (before the start of the therapy, in the middle of it, immediately after its completion and two weeks after the end of the treatment). The clinical examination (goniometric measurements of range of motion of the spine) and the evaluation of nerve root irritation (Laseque's and Mackiewicz's signs) was done twice - before and immediately after the treatment. At the same time the functional ability in patients in everyday activities using the Oswestry Disability Index (ODI) and Back Pain Functional Scale (BPFS) was evaluated too.
A statistical analysis of the obtained results was performed by means of the SPSS 17.0 suite (Softonic, USA). Qualitative variables were described by stating the number of observations with the feature variant (n) and its corresponding percentage. The qualitative-nominal data was calculated using the following dependence coefficients based on the Chi-squared test: Phi, Cramér's V, and for variables in ordinal scales: Kendall's Tau-b and Tau-c.
Quantitative variables were described based on their nonparametric distribution (verified by the Shapiro-Wilk and Kolmogorov-Smirnov tests) by providing descriptive characteristics: the mean, the median and the standard deviation. In order to compare differences between analogical parameters, the following nonparametric tests were used: Mann-Whitney U for two samples, Kruskal-Wallis for more than two samples. In the case of comparisons of equinumerous groups, a parametric test was used: a one-way analysis of variance ANOVA and post hoc comparisons.
- Conditions
- Back Pain
- Being tested
- Manual therapy, PNF, Manual therapy + PNF, Kinesiotherapy
- Keywords
- manual therapy, kinesiotherapy, pnf, back pain
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyProcedure or surgery
Manual therapy - the mobilisation of joint segments L4-L5 and L5-S1 and mobilisation techniques for soft tissues (functional massage of soft tissues and skin relaxation using the methods of stretching).
PNFProcedure or surgery
Also called Proprioceptive Neuromuscular Facilitation
The PNF method - the movement patterns of the scapulae and the pelvis were used (anterior and posterior elevations and depression) along with the patterns of upper extremities (e.g. bending, abduction, outward rotation) and lower extremities (e.g. bending, abduction, inward rotation with bending of the knee joint).
Manual therapy + PNFProcedure or surgery
Also called Manual therapy + Proprioceptive Neuromuscular Facilitation
Combination therapy - Manual therapy and Proprioceptive Neuromuscular Facilitation
KinesiotherapyProcedure or surgery
Traditional kinesiotherapy in the form of active slow exercises of back muscles, abdominal and gluteal muscles on a mat. The patients participated in a uniform treatment programme consisting of ten exercises. Each of the exercises was performed in a number of 20 repetitions.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy | Experimental | A group of 50 people using manual therapy as a treatment method. Receives: Procedure: Manual therapy |
| PNF | Experimental | A group of 50 people using PNF (Proprioceptive Neuromuscular Facilitation) as a treatment method. Receives: Procedure: PNF |
| Manual therapy + PNF | Experimental | A group of 50 people using combination therapy - manual therapy and PNF. Receives: Procedure: Manual therapy + PNF |
| Kinesiotherapy | Experimental | A group of 50 people using traditional kinesiotherapy (exercises) as a treatment method. Receives: Procedure: Kinesiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale of pain (VAS)
Visual analogue scale of pain (VAS) evaluates intensity of pain in a scale of 0 to 10. Maximum score meaning the highest level of pain.
Measured: visual analogue pain scale (VAS) was carried out four times (before the start of the therapy, after 5 days of therapy, immediately after its completion and two weeks after the end of the treatment).
Secondary outcomes (3)
Modified Laitinen's pain questionnaire
The Laitinen questionnaire took into account four indicators evaluated in a scale of 0 to 4: the intensity of pain, the frequency of its occurrence, the use of analgesic medications and limitation of the patient's motor activity. A research subject could have been granted from 0 to 16 points, the maximum score meaning the highest level of pain.
Measured: A modified Laitinen's pain questionnaire was carried out four times (before the start of the therapy, after 5 days of therapy, immediately after its completion and two weeks after the end of the treatment).
Stratford's back pain functional scale (BPFS)
In Stratford's scale (BFPS), the research subjects assessed twelve actions related to everyday life activity in a scale of 0 to 5. The result fell within a range of 0 to 60 points, whereby the higher the final result, the lower was the level of pain.
Measured: Stratford's back pain functional scale (BPFS) was done twice - before and immediately after the treatment.
Goniometric examination of active movements in the thoracic-lumbar spine
The scope of examinations included the measurements of bending mobility (the "fingers-floor" test), right and left rotation of the thoracic-lumbar spine, as well as lateral bending of the torso to the right and to the left.
Measured: Goniometric examination of active movements in the thoracic-lumbar spine were done twice - before and immediately after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start1 Mar 2014
- Primary completion30 Apr 2016
- Study completion30 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Crossover
- Model description
- The patients were randomly divided into four groups of 50 people: the manual therapy group (A), the PNF method group (B), the manual therapy and the PNF method group (C), as well as the traditional kinesiotherapy group (D). Therapy in all groups proceeded for ten days during a period of two weeks. Measurements of pain intensity using visual analogue pain scale (VAS) and a modified Laitinen's pain questionnaire were carried out four times (before the start of the therapy, in the middle of it, immediately after its completion and two weeks after the end of the treatment). The clinical examination (goniometric measurements of range of motion of the spine) and the evaluation of nerve root irritation (Laseque's and Mackiewicz's signs) was done twice - before and immediately after the treatment.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kamil Zaworski, Study chair, MU Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733964
- Sponsor's protocol ID
- MU Lublin
- Status last verified
- Nov 2018
- First submitted
- 8 Oct 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Manual Therapy and Proprioceptive Neuromuscular Facilitation (PNF) Compared With Traditional Kinesiotherapy in the Treatment of Non-Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT03733964
- Acronym / sponsor ID
- MU Lublin
- Conditions
- Back Pain
- Keywords
- manual therapy, kinesiotherapy, pnf, back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 7 Nov 2018 (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.
The aim of the study was to determine whether the use of combination therapy consisting of manual therapy and proprioceptive neuromuscular facilitation (PNF) is more effective than the use of the techniques of manual therapy, PNF method or traditional physiotherapy as single methods in the treatment of non-specific low back pain.
The study was designed as single-blinded Randomized Controlled Trial (RCT) and conducted on a group of 200 patients of Hospital in Parczew. The patients were randomly divided into four 50-person groups: A used manual therapy, B - PNF, C - manual therapy and PNF, and D -kinesiotherapy. Pain intensity was measured using VAS and Laitinen's questionnaire. Functional disability was assessed using Oswestry Disability Index (ODI) and Back Pain Functional Scale (BPFS).
. The hypotheses were:
- The greatest reduction of pain is observed in the combined therapy group consisting of manual therapy and PNF method
- The range of movement of the lumbar spine is the most improved in the combination therapy group consisting of manual therapy and PNF method.
- Neurological symptoms assessed by neurodynamic tests are reduced to the greatest extent in the combined therapy group consisting of manual therapy and PNF method.
- The degree of disability due to back pain as assessed using the Oswestry Disability Index (ODI) decreases in all study groups.
- The functioning of patients in everyday life assessed using Back Pain Functional Scale (BPFS) shows the biggest improvement in the combination therapy group consisting of manual therapy and PNF method.
Detailed description
The research was conducted upon acquiring an approval of the Bioethical Commission of the Medical University in Lublin, no. KE-0254/14/2014.
The patients were qualified for physiotherapeutic treatment by a physician working in the given centre - a specialist on medical rehabilitation or balneotherapy and physical medicine. None of the physicians were personally involved in the preparation and the manner of performing the test. Before commencing the tests, each patient was familiarised with their course, expressed their informed written consent for participation and random assignment to a specified tested group.
The following selection criteria were used for the groups: the patients' age between 25 and 55, symptomatic spinal disc herniation of the lumbar spine at levels L4-L5 and/or L5-S1, confirmed by imaging examinations (MR, TK), and the patients' lack of use of non-steroid anti-inflammatory medications (NSAID) for a period of at least one week before the start of the tests. People with cancer, past spinal injuries with damage to anatomical structures and osteoporosis were excluded from the tests. Patients who did not qualify also included those with a severe inflammatory condition (sciatica) and a massive hernia of the intervertebral disc which required surgical treatment.
The patients were randomly divided into four groups of 50 people: the manual therapy group (A), the PNF method group (B), the manual therapy and the PNF method group (C), as well as the traditional kinesiotherapy group (D).
The analgesic effectiveness of the used treatment was evaluated by means of the commonly used 10-point visual analogue scale of pain (VAS), the modified Laitinen questionnaire of pain indicators and Stratford's back pain functional scale (BPFS).
The functional evaluation involved a goniometric examination of active movements in the thoracic-lumbar spine.
Measurements of pain intensity using visual analogue pain scale (VAS) and a modified Laitinen's pain questionnaire were carried out four times (before the start of the therapy, in the middle of it, immediately after its completion and two weeks after the end of the treatment). The clinical examination (goniometric measurements of range of motion of the spine) and the evaluation of nerve root irritation (Laseque's and Mackiewicz's signs) was done twice - before and immediately after the treatment. At the same time the functional ability in patients in everyday activities using the Oswestry Disability Index (ODI) and Back Pain Functional Scale (BPFS) was evaluated too.
A statistical analysis of the obtained results was performed by means of the SPSS 17.0 suite (Softonic, USA). Qualitative variables were described by stating the number of observations with the feature variant (n) and its corresponding percentage. The qualitative-nominal data was calculated using the following dependence coefficients based on the Chi-squared test: Phi, Cramér's V, and for variables in ordinal scales: Kendall's Tau-b and Tau-c.
Quantitative variables were described based on their nonparametric distribution (verified by the Shapiro-Wilk and Kolmogorov-Smirnov tests) by providing descriptive characteristics: the mean, the median and the standard deviation. In order to compare differences between analogical parameters, the following nonparametric tests were used: Mann-Whitney U for two samples, Kruskal-Wallis for more than two samples. In the case of comparisons of equinumerous groups, a parametric test was used: a one-way analysis of variance ANOVA and post hoc comparisons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- The patients were randomly divided into four groups of 50 people: the manual therapy group (A), the PNF method group (B), the manual therapy and the PNF method group (C), as well as the traditional kinesiotherapy group (D). Therapy in all groups proceeded for ten days during a period of two weeks. Measurements of pain intensity using visual analogue pain scale (VAS) and a modified Laitinen's pain questionnaire were carried out four times (before the start of the therapy, in the middle of it, immediately after its completion and two weeks after the end of the treatment). The clinical examination (goniometric measurements of range of motion of the spine) and the evaluation of nerve root irritation (Laseque's and Mackiewicz's signs) was done twice - before and immediately after the treatment.
| Arm | Type | Receives |
|---|---|---|
| Manual therapy | Experimental | Procedure: Manual therapyA group of 50 people using manual therapy as a treatment method. |
| PNF | Experimental | Procedure: PNFA group of 50 people using PNF (Proprioceptive Neuromuscular Facilitation) as a treatment method. |
| Manual therapy + PNF | Experimental | Procedure: Manual therapy + PNFA group of 50 people using combination therapy - manual therapy and PNF. |
| Kinesiotherapy | Experimental | Procedure: KinesiotherapyA group of 50 people using traditional kinesiotherapy (exercises) as a treatment method. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- the patients' age between 25 and 55,
- symptomatic spinal disc herniation of the lumbar spine at levels L4-L5 and/or L5-S1,
- confirmed by imaging examinations (MR, TK),
- the patients' lack of use of non-steroid anti-inflammatory medications (NSAID) for a period of at least one week before the start of the tests.
Key exclusion criteria (3 listed)
- people with cancer,
- past spinal injuries with damage to anatomical structures and osteoporosis,
- patients with a severe inflammatory condition (sciatica) and a massive hernia of the intervertebral disc which required surgical treatment.
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 therapyManual therapy - the mobilisation of joint segments L4-L5 and L5-S1 and mobilisation techniques for soft tissues (functional massage of soft tissues and skin relaxation using the methods of stretching). | Procedure or surgery | Manual therapy |
| PNFAlso: Proprioceptive Neuromuscular FacilitationThe PNF method - the movement patterns of the scapulae and the pelvis were used (anterior and posterior elevations and depression) along with the patterns of upper extremities (e.g. bending, abduction, outward rotation) and lower extremities (e.g. bending, abduction, inward rotation with bending of the knee joint). | Procedure or surgery | PNF |
| Manual therapy + PNFAlso: Manual therapy + Proprioceptive Neuromuscular FacilitationCombination therapy - Manual therapy and Proprioceptive Neuromuscular Facilitation | Procedure or surgery | Manual therapy + PNF |
| KinesiotherapyTraditional kinesiotherapy in the form of active slow exercises of back muscles, abdominal and gluteal muscles on a mat. The patients participated in a uniform treatment programme consisting of ten exercises. Each of the exercises was performed in a number of 20 repetitions. | Procedure or surgery | Kinesiotherapy |
Primary outcome
Visual analogue scale of pain (VAS)
Time frame: visual analogue pain scale (VAS) was carried out four times (before the start of the therapy, after 5 days of therapy, immediately after its completion and two weeks after the end of the treatment).
Visual analogue scale of pain (VAS) evaluates intensity of pain in a scale of 0 to 10. Maximum score meaning the highest level of pain.
3 secondary outcomes
Modified Laitinen's pain questionnaire
Time frame: A modified Laitinen's pain questionnaire was carried out four times (before the start of the therapy, after 5 days of therapy, immediately after its completion and two weeks after the end of the treatment).
Stratford's back pain functional scale (BPFS)
Time frame: Stratford's back pain functional scale (BPFS) was done twice - before and immediately after the treatment.
Goniometric examination of active movements in the thoracic-lumbar spine
Time frame: Goniometric examination of active movements in the thoracic-lumbar spine were done twice - before and immediately after the treatment.
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 7 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
Kamil Zaworski study chair
MU Lublin
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, PNF and Manual therapy + PNF in people with Back Pain, run by Medical University of Lublin at 1 site in Poland.
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 4 inclusion and 3 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 7 Nov 2018. 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 Poland. 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?
Visual analogue scale of pain (VAS) (time frame: visual analogue pain scale (VAS) was carried out four times (before the start of the therapy, after 5 days of therapy, immediately after its completion and two weeks after the end of the treatment).). 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 7 Nov 2018.