The Effectiveness of Manual Therapy and PNF Compared With Kinesiotherapy in the Treatment of Non-specific Low Back Pain
Primary Purpose
Back Pain
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Manual therapy
PNF
Manual therapy + PNF
Kinesiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain focused on measuring manual therapy, kinesiotherapy, pnf, back pain
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Public Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Manual therapy
PNF
Manual therapy + PNF
Kinesiotherapy
Arm Description
A group of 50 people using manual therapy as a treatment method.
A group of 50 people using PNF (Proprioceptive Neuromuscular Facilitation) as a treatment method.
A group of 50 people using combination therapy - manual therapy and PNF.
A group of 50 people using traditional kinesiotherapy (exercises) as a treatment method.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT03733964
First Posted
October 8, 2018
Last Updated
November 5, 2018
Sponsor
Medical University of Lublin
1. Study Identification
Unique Protocol Identification Number
NCT03733964
Brief Title
The Effectiveness of Manual Therapy and PNF Compared With Kinesiotherapy in the Treatment of Non-specific Low Back Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2014 (Actual)
Primary Completion Date
April 30, 2016 (Actual)
Study Completion Date
April 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Lublin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
manual therapy, kinesiotherapy, pnf, back pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantCare ProviderInvestigator
Masking Description
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 author of this paper had no influence on the categorisation of patients into individual treatment groups. During the studies, the physicians performing the categorisation were not informed about the results of the used treatment. However, on request they could acquire information about the result of using the procedures for a single patient. They were also informed about the occurrence of any undesired events.
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual therapy
Arm Type
Experimental
Arm Description
A group of 50 people using manual therapy as a treatment method.
Arm Title
PNF
Arm Type
Experimental
Arm Description
A group of 50 people using PNF (Proprioceptive Neuromuscular Facilitation) as a treatment method.
Arm Title
Manual therapy + PNF
Arm Type
Experimental
Arm Description
A group of 50 people using combination therapy - manual therapy and PNF.
Arm Title
Kinesiotherapy
Arm Type
Experimental
Arm Description
A group of 50 people using traditional kinesiotherapy (exercises) as a treatment method.
Intervention Type
Procedure
Intervention Name(s)
Manual therapy
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
PNF
Other Intervention Name(s)
Proprioceptive Neuromuscular Facilitation
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Manual therapy + PNF
Other Intervention Name(s)
Manual therapy + Proprioceptive Neuromuscular Facilitation
Intervention Description
Combination therapy - Manual therapy and Proprioceptive Neuromuscular Facilitation
Intervention Type
Procedure
Intervention Name(s)
Kinesiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual analogue scale of pain (VAS)
Description
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.
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).
Secondary Outcome Measure Information:
Title
Modified Laitinen's pain questionnaire
Description
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.
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).
Title
Stratford's back pain functional scale (BPFS)
Description
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.
Time Frame
Stratford's back pain functional scale (BPFS) was done twice - before and immediately after the treatment.
Title
Goniometric examination of active movements in the thoracic-lumbar spine
Description
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.
Time Frame
Goniometric examination of active movements in the thoracic-lumbar spine were done twice - before and immediately after the treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamil Zaworski
Organizational Affiliation
MU Lublin
Official's Role
Study Chair
Facility Information:
Facility Name
Public Hospital
City
Parczew
State/Province
Lubleskie
ZIP/Postal Code
21-200
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effectiveness of Manual Therapy and PNF Compared With Kinesiotherapy in the Treatment of Non-specific Low Back Pain
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