The Effectiveness of Manual Therapy and PNF Compared With Kinesiotherapy in the Treatment of Non-specific Low Back Pain

NCT03733964 | Completed

• 1 other identifier: MU Lublin
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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:

1. 1.The greatest reduction of pain is observed in the combined therapy group consisting of manual therapy and PNF method
2. 2.The range of movement of the lumbar spine is the most improved in the combination therapy group consisting of manual therapy and PNF method.
3. 3.Neurological symptoms assessed by neurodynamic tests are reduced to the greatest extent in the combined therapy group consisting of manual therapy and PNF method.
4. 4.The degree of disability due to back pain as assessed using the Oswestry Disability Index (ODI) decreases in all study groups.
5. 5.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.

Conditions

Back Pain

Keywords

manual therapy; kinesiotherapy; pnf; back pain

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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)

  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

  Goniometric examination of active movements in the thoracic-lumbar spine were done twice - before and immediately after the treatment.

Study Arms (4)

Manual therapy

EXPERIMENTAL

A group of 50 people using manual therapy as a treatment method.

Procedure: Manual therapy

PNF

EXPERIMENTAL

A group of 50 people using PNF (Proprioceptive Neuromuscular Facilitation) as a treatment method.

Procedure: PNF

Manual therapy + PNF

EXPERIMENTAL

A group of 50 people using combination therapy - manual therapy and PNF.

Procedure: Manual therapy + PNF

Kinesiotherapy

EXPERIMENTAL

A group of 50 people using traditional kinesiotherapy (exercises) as a treatment method.

Procedure: Kinesiotherapy

Interventions

Manual therapy PROCEDURE

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).

Manual therapy

PNF PROCEDURE

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).

Also known as: Proprioceptive Neuromuscular Facilitation

PNF

Manual therapy + PNF PROCEDURE

Combination therapy - Manual therapy and Proprioceptive Neuromuscular Facilitation

Also known as: Manual therapy + Proprioceptive Neuromuscular Facilitation

Manual therapy + PNF

Kinesiotherapy PROCEDURE

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.

Kinesiotherapy

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Lublin: lead

Study Sites (1)

Public Hospital

Parczew, Lubleskie, 21-200, Poland

Location

MeSH Terms

Conditions

Back Pain

Interventions

Musculoskeletal Manipulations; Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Exercise Therapy; Aftercare; Continuity of Patient Care; Patient Care; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kamil Zaworski

  MU Lublin

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: November 7, 2018
• Study Start: March 1, 2014
• Primary Completion: April 30, 2016
• Study Completion: April 30, 2016
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

PL (1)