Myofascial Trigger Point Release and Paced Breathing Training for Chronic Low Back Pain

NCT ID: NCT04107597

Last Updated: 2019-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-01
• Study Completion Date: 2009-06-12

Brief Summary

A study to explore whether two different treatment approaches, myofascial trigger point release and core stabilization exercises, both with and without additional paced breathing training, can help patients with chronic low back pain (CLBP) and whether one of the two treatments is superior.

Detailed Description

This is a randomized controlled trial to evaluate the effect of myofascial trigger point release therapy compared to core stabilization exercises, both with and without additional paced breathing training, on patients with chronic low back pain (CLBP). The main focus is on changes in pain severity, anxiety and depression, heart rate variability, and use of analgesic medication. Outcomes are measured at baseline (pre-intervention), after ten treatments (post-intervention), at three- and at six-month follow-up.

Conditions

Chronic Low-back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Core stabilization exercises

Patients with CLBP who practice core stabilization exercises

Group Type: EXPERIMENTAL

Core stabilization exercises

Intervention Type: OTHER

Twelve specific exercises following a standard protocol aiming at an intersegmental stabilization of the spine and strengthening and stabilization of specific muscle groups. The exercises are performed under instruction and supervision by a physiotherapist twice per week for 45 minutes

Core stabilization exercises and paced breathing training

Patients with CLBP who practice core stabilization exercises combined with paced breathing training

Group Type: EXPERIMENTAL

Core stabilization exercises and paced breathing training

Intervention Type: OTHER

Twelve specific exercises following a standard protocol aiming at an intersegmental stabilization of the spine and strengthening and stabilization of specific muscle groups. The exercises are performed under instruction and supervision by a physiotherapist twice per week for 45 minutes. In addition, the participants practice paced breathing training (before and during the CSE sessions as well as 15 minutes twice per day at home) which has a modulating effect on the autonomic nervous system

Myofascial trigger point release

Patients with CLBP who receive myofascial trigger point release therapy

Group Type: EXPERIMENTAL

Myofascial trigger point release

Intervention Type: OTHER

A standard protocol of 12 myofascial and trigger point release grips followed by so-called roll-down maneuvers and manual rhythmical oscillation, applied to specific muscles and muscle groups. The treatment is applied twice per week for 45 minutes

Myofascial trigger point release and paced breathing training

Patients with CLBP who receive myofascial trigger point release therapy combined with paced breathing training

Group Type: EXPERIMENTAL

Myofascial trigger point release and paced breathing training

Intervention Type: OTHER

A standard protocol of 12 myofascial and trigger point release grips followed by so-called roll-down maneuvers and manual rhythmical oscillation, applied to specific muscles and muscle groups. The treatment is applied twice per week for 45 minutes. In addition, the participants practice paced breathing training (before and during the MTPR sessions as well as 15 minutes twice per day at home) which has a modulating effect on the autonomic nervous system

Interventions

Core stabilization exercises

Twelve specific exercises following a standard protocol aiming at an intersegmental stabilization of the spine and strengthening and stabilization of specific muscle groups. The exercises are performed under instruction and supervision by a physiotherapist twice per week for 45 minutes

Intervention Type: OTHER

Core stabilization exercises and paced breathing training

Twelve specific exercises following a standard protocol aiming at an intersegmental stabilization of the spine and strengthening and stabilization of specific muscle groups. The exercises are performed under instruction and supervision by a physiotherapist twice per week for 45 minutes. In addition, the participants practice paced breathing training (before and during the CSE sessions as well as 15 minutes twice per day at home) which has a modulating effect on the autonomic nervous system

Intervention Type: OTHER

Myofascial trigger point release

A standard protocol of 12 myofascial and trigger point release grips followed by so-called roll-down maneuvers and manual rhythmical oscillation, applied to specific muscles and muscle groups. The treatment is applied twice per week for 45 minutes

Intervention Type: OTHER

Myofascial trigger point release and paced breathing training

A standard protocol of 12 myofascial and trigger point release grips followed by so-called roll-down maneuvers and manual rhythmical oscillation, applied to specific muscles and muscle groups. The treatment is applied twice per week for 45 minutes. In addition, the participants practice paced breathing training (before and during the MTPR sessions as well as 15 minutes twice per day at home) which has a modulating effect on the autonomic nervous system

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Written informed consent
• Age between 20 and 70 years
• LBP at least once a week during the last three months
• Pain intensity rated at least 4 on an 11-point scale (0=no pain, 10=worst pain imaginable)
• Muscular pain during flexion, extension and lateral flexion

Exclusion Criteria

• Acute hernia
• Acute local or generalized inflammation
• Neurological disorders such as multiple sclerosis, Parkinson's disease, hemiplegia
• Fibromyalgia
• Radicular symptoms (Lasègue's sign, weakness of foot dorsiflexion muscle, needles or tingling in the legs)
• Paraspinal tumors or metastases
• Cancer under chemo- or radio-surgical treatment or requiring such during the next 12 months
• Leg prostheses
• Rheumatic, cardiovascular or chronic pulmonary condition precluding 45-minute physical therapy (contraindication declared by a physician)
• Severe depression or severe anxiety currently requiring psychotherapy and/or pharmacotherapy
• Suicidal tendencies
• Drug abuse or addiction
• Pregnancy existing or planned during the study period

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center für Integrative Therapie Christopher Gordon

UNKNOWN

Sponsor Role: collaborator

University Hospital Tuebingen

OTHER

Sponsor Role: collaborator

Die Filderklinik

UNKNOWN

Sponsor Role: collaborator

Orthopädisch-Unfallchirurgische Praxis Dr Lembeck & Dr Pampel

UNKNOWN

Sponsor Role: collaborator

ARCIM Institute Academic Research in Complementary and Integrative Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Vagedes, Dr.

Role: PRINCIPAL_INVESTIGATOR

Arcim Institute

Locations

Arcim Institute

Filderstadt, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

LBP_02

Identifier Type: -

Identifier Source: org_study_id