Psychological Predictors of Pain and Disability in Patients With Chronic Low Back Pain After Manual Therapy

NCT07306312 | Enrolling By Invitation

• 1 other identifier: 10130/25/TFSKTH - 04/04/25
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain has been reported to cause more disability than any other musculoskeletal health condition worldwide. About eight out of ten people will experience back pain at least once in their lifetime. The parameters that are usually evaluated in a low back pain condition are pain, functional disability and range of motion of the lumbar spine. There are studies that associate psychological conditions (self-efficacy, kinesiophobia, catastrophology, depression, anxiety) with pain and functional disability in patients with low back pain. However, the ability of psychological factors to predict progression after a program of physical therapy or therapeutic methods is not well studied. The main purpose of this study is to investigate the predictive potential of psychological factors in the improvement of pain and functional disability after a manual therapy physiotherapy program in patients with chronic low back pain. A secondary purpose is to investigate the predictive potential of psychological factors in the improvement of pain and functional disability following a program of Pain Neuroscience Education (PNE) in patients with chronic low back pain. In addition, as a secondary purpose, it will be to investigate the effect of combining manual therapy therapy with PNE compared to manual therapy alone in patients with chronic low back pain. This study will involve 60 people aged 18-65 with chronic low back pain, who will be randomly divided by lots into 2 groups of 30 people. The 1st group (30 people) will be treated with manual therapy based on Maitland's principles (interview, evaluation, mobilization), without any use of physiotherapy machines, but with the use of personalized exercises. The 2nd group (30 people) will do the same as group 1 and additional volunteers will participate in before, in a training program in Pain Neuroscience Education (PNE). The total number of sessions that each volunteer will receive will be 6, the duration of each session will be about 45 minutes, the frequency of the sessions will be 2 times a week and the total duration of the intervention will be 3 weeks. The associations between psychological states and clinical characteristics (pain, disability and range of motion) will be carried out with the Pearson or Spearman correlation coefficient depending on whether the data are parametric or not. Multiple regression models will also be created with predictive factors for psychological states and a predictive variable for each of the clinical parameters. The significance level will be set to p=0.05.

Conditions

Low Back Pain; Disability Physical; Manual Theapy

Keywords

pain; disability; manual therapy; low back pain; Pain Neuroscience Education; psychological factors; kinesiophobia; catastrophizing; anxiety; depression; self-efficacy

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  The assessment of pain will be recorded with the Numeric Pain Rating Scale - NPRS questionnaire. "Zero is equivalent to no pain and 10 indicates the worst possible pain."

  From enrollment to the end of treatment at 3 weeks and after 6 months from the enrollment

Secondary Outcomes (1)

• Disability

  From enrollment to the end of treatment at 3 weeks and after 6 months from the enrollment

Study Arms (2)

Manual therapy

EXPERIMENTAL

Participants with low back pain will be treated with manual therapy based on Maitland's principles

Other: Manual therapy

Manual therapy plus Pain Neuroscience Education

ACTIVE COMPARATOR

Participants with low back pain will be treated with manual therapy based on Maitland's principles but before that, volunteers will be participated, in a Pain Neuroscience Education (PNE) program

Other: Manual therapy plus Pain Neuroscience Education

Interventions

Manual therapy OTHER

Manual therapy based on Maitland's approach

Manual therapy

Manual therapy plus Pain Neuroscience Education OTHER

Manual therapy based on Maitland's approach with Pain Neuroscience Education

Manual therapy plus Pain Neuroscience Education

Eligibility Criteria

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

You may qualify if:

• Participants should be between 18 and 65 years of age,
• the pain in the lumbar region should last for more than 3 months, with at least one attack per week,
• they should not have undergone physiotherapy in the last 6 months prior to the intervention
• have a good knowledge of the Greek language and an adequate level of knowledge, to be informed and sign the consent form and questionnaires

You may not qualify if:

• people with clinical conditions that are contraindicated for physiotherapy,
• patients who report red flags,
• people with a history of lumbar surgery,
• people with diagnosed neuromuscular diseases that significantly impair movement,
• people with cardiovascular and respiratory diseases that cause severe shortness of breath or angina
• people with mental disorders, as long as they hinder communication and cooperation with the researcher.

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

Athens Scoliosis

Athens, Greece

Location

MeSH Terms

Conditions

Low Back Pain; Pain; Kinesiophobia; Anxiety Disorders; Depression

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Zacharias Dimitriadis

  University of Thessaly

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD candidate, Physiotherapy Department University of Thessaly

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 29, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 18, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)