NCT03493438

Brief Summary

Low back pain is an extremely common health problem that most people suffers at any point in their life. Low back pain is the leading cause of activity limitation and work absence throughout much of the world and it causes some economic problems for just not only individuals but also governments. ) The purpose of the study was to investigate the effects of different physical therapy techniques on pain, function and core stability in patients with low back pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 26, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2018

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

April 4, 2018

Last Update Submit

July 7, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Pain Intensity

    Pain intensity was measured with visual analog scale (VAS). For VAS, it is desirable that patients express their pain with a (X) mark on a scale of 100 mm. According to this, "0" means that the patients have no pain and "100" means that they have worst pain. The distance between the marking point and the start of the line is measured in millimeters and the numerical value found determines the pain intensity of patients. The total pain intensity is measured with the scale of Likert type of 6 points. In this scale "0" indicates no pain and "5" indicates worst pain.

    6 weeks

  • Functionality

    The Oswestry Low Back Pain Questionnaire was used to assess the functioning of daily living activities in low back pain. There are 10 questions in the questionnaire, 6 options in each question, ranging from 0 to 5 points. The patient is asked to choose the expression that best describes the situation. The highest score was 50, with mild functional impairment between 1-10 points, moderate functional impairment between 11-30 points, and severe functional impairment between 31-50 points. The Turkish version of the questionnaire was validated and reliable.

    6 weeks

  • Kinesiophobia

    Individuals' kinesiophobia were assessed by using the Tampa Kinesiophobia Scale. The questionnaire is a 17-item measure designed to measure fear of movement / re-injury. The scale includes injury / re-injury and fear-avoidance parameters in work-related activities. A 4-point Likert Scale (1 = strongly disagree, 4 = fully agree) is used on the scale. A total score is calculated after the reversal of 4, 8, 12, and 16 questions. The patient has a total score between 17-68. The high score on the scale indicates that the kinesophobia is also high. The Turkish version of the questionnaire was validated and reliable

    6 weeks

  • core stability

    Core stability was assessed with the pressure device (Stabilizer Pressure Biofeedback, USA, Chattanooga Group, Hixson, TN). For transversus abdominus (TrA) and multifidus (MF) muscle strength the patients performed the drawing-in maneuver in a supine position, with their knees flexed at 90°. To perform abdominal drawing-in maneuver, all the subjects were instructed to slowly draw in their lower abdomen as if they were holding their urine and then draw up their pelvic floor muscle so that it could contract, together with their lower abdomen, while continuing normal breathing. The end part of the pressure device was placed on the posterior superior iliac spine. The pressure gauge was set to indicate 40 mmHg before the drawing-in maneuver began. The subjects were told to increase the pressure by 10 mmHg using the drawing-in maneuver on the verbal instruction, "start", and to maintain the state for 5 seconds. Pressure changes were recorded as mmHg.

    6 weeks

Secondary Outcomes (1)

  • patient satisfaction

    6 weeks

Study Arms (4)

Relaxation Group

EXPERIMENTAL

Patients performed Jacobson relaxation technique in supine position. Respiration control and various visual imaging techniques were used during the technique. Relaxation exercises were made within the supervision of a physiotherapist. The application period was 20 minutes for one session, 3 days a week and totally six weeks.

Other: exercise

Proprioceptive Neuromuscular Facilitation Group

EXPERIMENTAL

Patients exercised with proprioceptive neuromuscular facilitation technique for trunk muscles using chopping and lifting patterns with ritmic initiation PNF exercises were made by the physiotherapist. The application period was 20 minutes for one session, 3 days a week and totally six weeks.

Other: exercise

Core stabilization group

EXPERIMENTAL

Patients had core stabilization exercises that involved spinal mobility. The patients performed the drawing-in maneuver within various visual imaging techniques during all exercises, especially with respiratory control. Exercises were made within the supervision of a physiotherapist. The application period was 20 minutes for one session, 3 days a week and totally six weeks.

Other: exercise

control group

OTHER

Patients in the control group were told the importance of a single session exercise

Other: exercise

Interventions

A hot pack and conventional transcutaneous electrical stimulation (TENS) will be applied with a Chattanoga Intelect® stimulator for 20 minutes at a frequency of 100 Hz and a transition time of 60 μs. The duration of application was 3 days per week and six weeks for each of the four groups. These practices were also applied to individuals in all four groups.

Also known as: A hot pack, conventional transcutaneous electrical stimulation (TENS) and exersice
Core stabilization groupProprioceptive Neuromuscular Facilitation GroupRelaxation Groupcontrol group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients had to have LBP for at least 3 months,
  • Patients who reported osteoarthritis or disk lesions (without neurologic compromise) with or without leg pain,
  • Patients between 18 and 65 years of age,

You may not qualify if:

  • Patients were excluded if they demonstrated any of the following;
  • They had neurologic signs, specific spinal pathology (eg, malignancy, inflammatory joint disease, bone disease),
  • They had undergone back and lower extremity surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University

Ankara, 06790, Turkey (Türkiye)

Location

MeSH Terms

Interventions

ExerciseTranscutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaElectric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSOC. PROF.

Study Record Dates

First Submitted

April 4, 2018

First Posted

April 10, 2018

Study Start

March 26, 2018

Primary Completion

June 26, 2018

Study Completion

June 26, 2018

Last Updated

July 8, 2020

Record last verified: 2020-07

Locations