Effect of Physiotherapeutic Interventions on Quality of Life in Patients With Chronic Low Back Pain. (Study 2)

NCT03309540 | Unknown DMC

• 1 other identifier: EBP4MTOR02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effect on QoL, PI and the AROM° in patients with non-specific chronic low back pain. This after following an episode of 6 weeks 2 times a week physiotherapeutic back rehabilitation according to the 4 times T method by orthopaedic disorder ® (4MTOR®). The results in this research will be analyzed and reported. In this study, 7 dependent variables will be independently examined relative to 2 independent variables.

Conditions

Chronic Low Back Pain; Physiotherapy; Quality of Life; Range of Motion; Pain Intensity

Keywords

Low back/lumbar spine; Multimodal Physical therapy; Quality of life; Range of Motion; Pain

Outcome Measures

Primary Outcomes (8)

• First measurment: Quality of life, EQ-5D-3L-index

  The EQ-5D-3L-index will analyze the participants Quality of life (QoL). Each question in the EQ-5D-3L-index includes one dimension of QoL: mobility, self-care, daily activities, pain/discomfort \& anxiety/depression. Each dimension has 3 levels ( having no problems, having some or moderate problems, being unable to do/having extreme problems) and gets a separate score.The scores can be combined in combination with an assessment of the health status they represent, this rating is expressed in weight or utility (1,000 = no problems at all) to (-0,329= extreme problems). Description of the QoL can be transformed into a QoL assessment by means of a formula. These ratings are based on judgments of the general population of all possible combinations of QoL on the different dimensions. An improvement in quality of life will be assumed when p\<α=0.05. Within time: W0-W3 Between groups: EGR versus SGR. The results are shown for all variables in a table.

  Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3)

• Second measurment: Quality of life, EQ-5D-3L-index

  The EQ-5D-3L-index will analyze the participants Quality of life (QoL). Each question in the EQ-5D-3L-index includes one dimension of QoL: mobility, self-care, daily activities, pain/discomfort \& anxiety/depression. Each dimension has 3 levels ( having no problems, having some or moderate problems, being unable to do/having extreme problems) and gets a separate score.The scores can be combined in combination with an assessment of the health status they represent, this rating is expressed in weight or utility (1,000 = no problems at all) to (-0,329= extreme problems). Description of the QoL can be transformed into a QoL assessment by means of a formula. These ratings are based on judgments of the general population of all possible combinations of QoL on the different dimensions. An improvement in quality of life will be assumed when p\<α=0.05.. Within time: W3-W7 Between groups: EGR versus SGR. The results are shown for all variables in a table.

  Timespad registration: Week 3/intermediate measurement (W3), week 7/ post measurement (W7)

• Third measurment: Quality of life, EQ-5D-3L-index

  The EQ-5D-3L-index will analyze the participants Quality of life (QoL). Each question in the EQ-5D-3L-index includes one dimension of QoL: mobility, self-care, daily activities, pain/discomfort \& anxiety/depression. Each dimension has 3 levels ( having no problems, having some or moderate problems, being unable to do/having extreme problems) and gets a separate score.The scores can be combined in combination with an assessment of the health status they represent, this rating is expressed in weight or utility (1,000 = no problems at all) to (-0,329= extreme problems). Description of the QoL can be transformed into a QoL assessment by means of a formula. These ratings are based on judgments of the general population of all possible combinations of QoL on the different dimensions. An improvement in quality of life will be assumed when p\<α=0.05. Within time: W0-W7 Between groups: EGR versus SGR. The results are shown for all variables in a table.

  Timespad registration: Week 0/baseline measurement (W0)- Week 7/ post measurement (W7)

• Fourth measurment: Quality of life, EQ-5D-3L-index

  The EQ-5D-3L-index will analyze the participants Quality of life (QoL). Each question in the EQ-5D-3L-index includes one dimension of QoL: mobility, self-care, daily activities, pain/discomfort \& anxiety/depression. Each dimension has 3 levels ( having no problems, having some or moderate problems, being unable to do/having extreme problems) and gets a separate score.The scores can be combined in combination with an assessment of the health status they represent, this rating is expressed in weight or utility (1,000 = no problems at all) to (-0,329= extreme problems). Description of the QoL can be transformed into a QoL assessment by means of a formula. These ratings are based on judgments of the general population of all possible combinations of QoL on the different dimensions. An improvement in quality of life will be assumed when p\<α=0.05. Within time: W7-W12 Between groups: EGR versus SGR. The results are shown for all variables in a table.

  Timespad registration: Week 7/ post measurement (W7) and week 12 follow up measurement (W12)

• First measurment: EQ- visual analogue scale (VAS)

  The EQ VAS records the respondent's self-rated health on a 20 cm vertical (0-100 score), visual analogue scale with endpoints labelled 'the best health (100) you can imagine' and 'the worst health you can imagine (0) '. This information can be used as a quantitative measure of health as judged by the individual respondents. An improvement in quality of life will be assumed when p\<α=0.05. For the EQ-VAS we used the minimum important change (MIC) for VAS 15 points Within time: W0-W3 Between groups: EGR versus SGR. The results are shown for all variables in a table.

  Time Frame: Timespad registration: Week 0/baseline measurement (W0) - week 3/intermediate measurement (W3)

• Second measurment: EQ- visual analogue scale (VAS)

  The EQ VAS records the respondent's self-rated health on a 20 cm vertical (0-100 score), visual analogue scale with endpoints labelled 'the best health (100) you can imagine' and 'the worst health you can imagine (0) '. This information can be used as a quantitative measure of health as judged by the individual respondents. An improvement in quality of life will be assumed when p\<α=0.05. For the EQ-VAS we used the minimum important change (MIC) for VAS 15 points Within time: W3-W7 Between groups: EGR versus SGR. The results are shown for all variables in a table.

  Timespad registration: Week 3/intermediate measurement (W3), week 7/ post measurement (W7)

• Third measurment: EQ- visual analogue scale (VAS)

  The EQ VAS records the respondent's self-rated health on a 20 cm vertical (0-100 score), visual analogue scale with endpoints labelled 'the best health (100) you can imagine' and 'the worst health you can imagine (0) '. This information can be used as a quantitative measure of health as judged by the individual respondents. An improvement in quality of life will be assumed when p\<α=0.05. For the EQ-VAS we used the minimum important change (MIC) for VAS 15 points Within time: W0-W7 Between groups: EGR versus SGR. The results are shown for all variables in a table.

  Timespad registration: Week 0/baseline measurement (W0)- Week 7/ post measurement (W7)

• Fourth measurment: EQ- visual analogue scale (VAS)

  The EQ VAS records the respondent's self-rated health on a 20 cm vertical (0-100 score), visual analogue scale with endpoints labelled 'the best health (100) you can imagine' and 'the worst health you can imagine (0) '. This information can be used as a quantitative measure of health as judged by the individual respondents. An improvement in quality of life will be assumed when p\<α=0.05. For the EQ-VAS we used the minimum important change (MIC) for VAS 15 points Within time: W7-W12 Between groups: EGR versus SGR. The results are shown for all variables in a table.

  Timespad registration: Week 7/ post measurement (W7) and week 12 follow up measurement (W12)

Secondary Outcomes (5)

• AROM° thoracolumbar-pelvic flexion (TLPF)

  Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)

• AROM° thoracolumbar- pelvic extension (TLPE)

  Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)

• AROM° isolated lumbar flexion(ILF)

  Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)

• Pain intensity flexion (0-10)

  Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)

• Pain intensity extension (0-10)

  Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)

Study Arms (2)

experimental group (EGR)

EXPERIMENTAL

Physical therapy intervention. In the experimental group (EGR), the 4MTOR® treatment method will be used for LBP. This 4MTOR® uses the following steps in a decision tree: T1 Testing (Physiotherapeutic examination), T2 Triggering (Manual Techniques), T3 Taping (Elastic Tape) and T4 Training (medical rehabilitation exercises).

Other: Physioterapy intervention

Sham group (SGR)

SHAM COMPARATOR

Physical therapy intervention. The participants in the SGR received a sham multimodal physiotherapeutic intervention as control intervention, in which Sham technique were applied. The interventions consisted of combining Sham manual interventions, elastic tapes according to Kaze and Evidence Based Practice Therapy. The protocol in the SGR follows the similar steps: Testing, Taping, Triggering and Training like the 4MTOR®.

Other: Physioterapy intervention

Interventions

Physioterapy intervention OTHER

In the experimental group (EGR), the 4MTOR® treatment method will be used for LBP. This 4MTOR® uses the following steps in a decision tree: T1 Testing (Physiotherapeutic examination), T2 Triggering (Manual Techniques), T3 Taping (Elastic Tape) and T4 Training (medical rehabilitation exercises). The participants in the SGR received a sham multimodal physiotherapeutic intervention as control intervention, in which Sham technique were applied. The interventions consisted of combining Sham manual interventions, elastic tapes according to Kaze32 and Evidence Based Practice Therapy (Appendix III). The protocol in the SGR follows the similar steps: Testing, Taping, Triggering and Training like the 4MTOR®.

Sham group (SGR); experimental group (EGR)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants are included when they meet the following criteria:
• NSP-CLBP from 12 weeks and longer that are continuously present (with and without recurrent complaints)
• Age between 20 and 60 years
• Not yet treated by the 4MTOR®.

You may not qualify if:

• Participants are excluded when they meet the following criteria:
• Radiological disturbing pain beyond knee
• Extremely serious neurological disorder symptoms
• Overall malaise
• Spinal cord malignancy
• Unexplained weight loss
• Prolonged corticosteroid use
• Osteoporotic vertebral fracture
• Spondylitis ankylopoetics
• Spinal stenosis
• Rheumatic arthritis
• Vertebral fracture
• Severe deformity of the spinal cord

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• Committee of Medical Ethics University Hospital University of Brussels, B.U.N. 143201627110.: collaborator
• Ethias liability policy: 45.147.458, insurance for the experiment on human subjects.: collaborator
• The EuroQol Research Foundation: collaborator
• This research is supported by the Fysio Science Institute® and is a non-profit institution.: collaborator

Study Sites (1)

Peter Vaes

Jette, Brussels Capital, 1090, Belgium

RECRUITING

Related Publications (1)

• Van Amstel R, Noten K, Malone S, Vaes P. Associations between trunk mobility, pain, and quality of life in individuals with chronic low back pain treated with different therapeutic protocols: Potential clinical parameters. J Back Musculoskelet Rehabil. 2025 Jul 14:10538127251358730. doi: 10.1177/10538127251358730. Online ahead of print.

  PMID: 40653852 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Peter P Vaes, PhD

  University of Brussels, faculty of Rehabilitation science and physical therapy, faculty of Pharmacy and medicine, Brussels, Belgium

  STUDY DIRECTOR

Central Study Contacts

Robbert R.N. Amstel, MSc

CONTACT

0611763830; Robbert.Van.Amstel@vub.be

Peter P Vaes, PhD

CONTACT

+322 477 43 26; pvaes@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: University of Brussels Medical expertise and rehabilitation center IJsselstein
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of science

Model Details: Level of evidence 1b, One way, RMANOVA, mixed, Pilot RCT, design

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 13, 2017
• Study Start: October 31, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: October 12, 2018

Record last verified: 2018-10

Locations

BE (1)