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

NCT04107597 | Completed

• 1 other identifier: LBP_02
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

Chronic Low-back Pain; Myofascial Trigger Point Release; Core Stabilization Exercises; Paced Breathing Training; Pain Severity; Anxiety; Heart Rate Variability

Outcome Measures

Primary Outcomes (1)

• Post-intervention pain severity

  Self-reported severity of LBP after ten treatments with the assigned intervention, assessed with the 4-item pain severity score of the Brief Pain Inventory (BPI). The items are rated on an 11-point scale (0=no pain, 10=worst pain imaginable), the score is reported as the mean of the corresponding items.

  5 weeks

Secondary Outcomes (12)

• Pain severity at three-month follow-up

  Measured at three-month follow-up

• Pain severity at six-month follow-up

  Measured at six-month follow-up

• Change in pain interference

  Measured at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up

• Change in anxiety

  Measured at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up

• Change in depression

  Measured at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up

Study Arms (4)

Core stabilization exercises

EXPERIMENTAL

Patients with CLBP who practice core stabilization exercises

Other: Core stabilization exercises

Core stabilization exercises and paced breathing training

EXPERIMENTAL

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

Other: Core stabilization exercises and paced breathing training

Myofascial trigger point release

EXPERIMENTAL

Patients with CLBP who receive myofascial trigger point release therapy

Other: Myofascial trigger point release

Myofascial trigger point release and paced breathing training

EXPERIMENTAL

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

Other: Myofascial trigger point release and paced breathing training

Interventions

Core stabilization exercises 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

Core stabilization exercises and paced breathing training 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

Core stabilization exercises and paced breathing training

Myofascial trigger point release 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

Myofascial trigger point release and paced breathing training 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

Myofascial trigger point release and paced breathing training

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ARCIM Institute Academic Research in Complementary and Integrative Medicine: lead
• Center für Integrative Therapie Christopher Gordon: collaborator
• University Hospital Tuebingen: collaborator
• Die Filderklinik: collaborator
• Orthopädisch-Unfallchirurgische Praxis Dr Lembeck & Dr Pampel: collaborator

Study Sites (1)

Arcim Institute

Filderstadt, Baden-Wurttemberg, 70794, Germany

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Jan Vagedes, Dr.

  Arcim Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 27, 2019
• Study Start: April 1, 2008
• Primary Completion: December 18, 2008
• Study Completion: June 12, 2009
• Last Updated: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be made available upon publication for a duration of three months.
• Access Criteria: The data will be made available to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.

Locations

DE (1)