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OpenTrials
Completed

NCT Number: NCT04384185

Combined Treatment of Manual Therapy and Therapeutic Exercise in Patients With Low Back Pain

MAIN OBJECTIVE: to assess whether an exercise protocol on the lumbar musculature by adding manual therapy techniques on the diaphragm muscle has the same or greater effect on chronic non-specific lumbar pain than an isolated exercise protocol.

SECONDARY OBJECTIVES: to evaluate the effectiveness of a lumbar exercise protocol in chronic non-specific low back pain in isolation; To evaluate the effectiveness of both therapies in improving joint range in patients with chronic non-specific low back pain and, finally, to assess catastrophism and the avoidance of lumbar mobility when carrying out loaded movements.

HYPOTHESIS: that a lumbar exercise protocol combined with manual therapy treatment on the diaphragm is equal or more effective on pain in patients with chronic nonspecific low back pain than treatment with the same lumbar exercise protocol in isolation.

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Key information

Conditions

Low Back Pain, Mechanical Back Pain Exercise Training Low Back Pain Musculoskeletal Manipulations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grupo Fisioterapia y Dolor

Alcalá de Henares, Madrid, 28871, Spain

About this study

METHODOLOGY: A prospective randomized clinical trial with two types of intervention (lumbar exercise protocol and manual diaphragm therapy) will be carried out. The variables to be measured are pain, disability, mobility and kinesiophobia. It will be performed in two groups of 21 people who are of legal age, who have low back pain of more than 3 months duration and which is of non-specific origin.

The patients will be randomized and divided into two groups A (control) and B (experimental).

Group A will undergo an exercise protocol.

Group B will undergo the same protocol plus manual therapy techniques on diaphragm muscle. Study participants will have treatment twice a week for 8 weeks, the first information session and the second measurement-evaluation session in the first week of treatment. In the following 3 weeks the session will last 40 minutes for both groups. In the 4th week the established measurements will be carried out again.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Legal age
  • Non-specific Low-Back pain
  • Pain more 3 months

Exclusion criteria

  • subjects with lumbar herniation.
  • Spine canal stenosis
  • Subjects with neurological disease.
  • Lumbar surgery

Treatment and study plan

exercise protocol

Other

Exercises:

  • Pelvic tilt.
  • brinding.
  • cuadruped arm/leg raise.
  • Abdominal strengthening exercises.
  • Low-back muscles stretching.
  • The side bridge.
  • Side leg separation

Manual therapy

Other
  • Functional diaphragm balancing technique: gentle vertical pressure was applied for 5 minutes at the diaphragm level.
  • Muscle fiber stretching technique: a cranial traction was performed from the lower edge of the costal arches during the inspiratory breathing phase, for more than 10 respiratory cycles.
  • Phrenic-center inhibition technique (Figure 3C): the soft tissue was pumped during the expiratory phase by gently and simultaneously using both hands to create pressure in cranial and caudal direction, for more than 10 respiratory cycles.

Other names: Myofascial manipulation

Primary outcomes

  1. Low-back pain

    Time frame: Change from Baseline disability at 3 months

    The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient with lowback pain.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and ten the other end representing "worst pain." Subjects will be asked to rate their current pain with a mark on the scale.

Secondary outcomes

  1. Disability with Oswestry Disability Index

    Time frame: Change from Baseline disability at 3 months

    The Oswestry Disability Index (ODI) is a questionnaire used by clinicians and researchers to quantify disability for low back pain.The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible

  2. Lumbar range of motion

    Time frame: Change from Baseline disability at 3 months

    Mobility. It will be measured using an electronic inclinometer.The TiltMeter© -advanced level and inclinometer app is an inclinometer app of iPhone®. The investigation has demonstrated that the app possesses good to excellent reliability (ICC ≥ 0.77) and concurrent validity with a gravity-based inclinometer (r ≥ 0.86) for measuring standing isolated lumbar flexion and extension range of movement

  3. Kinesiophobia

    Time frame: Change from Baseline disability at 3 months

    Kinesiophobia was measured by an 11-item version of the Tampa Scale of Kinesiophobia (TSK-11). The 11 items of the scale each have 4 response options; all anchored with the answers "strongly disagree", which scores 1 point, and "strongly agree", which scores 4 points. The total sum score is calculated and can range between 11 and 44 points. A high score indicates strong fear of movement/(re)injury, i.e. high kinesiophobia. TSK-11 has been psychometrically evaluated and has shown good construct validity and reliability among older people (i.e. internal consistency (Cronbach alpha, 0.74-0.87) and test-retest reliability (ICC r = 0.747)

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

Effectiveness of a Therapeutic Exercise Protocol Combined With Manual Therapy Techniques on the Diaphragm Muscle in Patients With Low Back Pain

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 12, 2020
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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