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SELF-REGULATION IN STRESS AND CHRONIC LOW BACK PAIN: A RANDOMIZED CONTROLLED TRIAL EMPLOYING A VIBRO HRV-TRAINING AND MYOFASCIAL SELF-TREATMENT

SELF-REGULATION IN STRESS AND CHRONIC LOW BACK PAIN: A RANDOMIZED CONTROLLED TRIAL EMPLOYING A VIBRO HRV-TRAINING AND MYOFASCIAL SELF-TREATMENT - SELF-REGULATION IN STRESS AND CHRONIC PAIN

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00031284
Enrollment
34
Registered
2023-07-03
Start date
2016-01-11
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M54.5

Interventions

Group 1: Vibroshearing myofascial manipulation 3 sessions of 30 minutes per week for 3 weeks, then 2 sessions of 20 minutes per week for an additional 12 weeks. Simultaneously, heart rate variability

Sponsors

CIT Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Chronic back pain with prominence in the lumbar region for a duration of at least 3 months and a frequency of at least once a week; pain severity on a numerical rating scale (0-10) of at least 5 points; subcutaneous fat layer thickness on lumber area less than 2cm (measured with a skin fold applicator).

Exclusion criteria

Exclusion criteria: Acute herniated disc; acute local and general inflammations; neurological disorders; fibromyalgia; radicular symptoms with positive Laseque test and foot lifting dysfunction; paraspinal metastases or tumors; cancer diseases requiring chemotherapy, radio-therapy or surgical treatment over the next 12 months; characteristics of rheumatological, cardiovascular or pulmonary chronic diseases; severe depressions and severe anxiety disorders; suicidal tendency; drug abuse or addiction; pregnancy; adiposity; cardiac pacemaker.

Design outcomes

Primary

MeasureTime frame
All measurements taken pre intervention, post 3 weeks and post 13 weeks. 1. Participant's elasticity and stiffness laterally to the lumbar spine using a MyotonPRO 2. Pain sensitivity using Algometer-Indentometer 3. Range of motion using Mobee Med 4. Respiratory sinus arrhythmia using HRV Scanner Biosign

Secondary

MeasureTime frame
All measurements taken pre intervention, post 3 weeks and post 13 weeks. 1. Participant's pain and stress using the brief pain inventory (BPI) 2. Pain disability index (PDI) 3. Modified stress questionnaire (developed specifically for this study)

Countries

Germany

Contacts

Public ContactChristina Hörmann

CIT Research Institute

organisation@center-gordon.de+49 0711 2366321

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026