Effectiveness of Home Programs After Lumbar Spinal Decompression Surgery

NCT06014645 | Completed

• 1 other identifier: Bursa NRŞ RKÇ
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be conducted with volunteer patients who are followed up by Bursa Çekirge State Hospital Cekirge State Hospital Neurosurgery outpatient clinic and who have undergone lumbar decompression surgery and who meet the study criteria. The cases will be divided into 2 groups by randomization software. The control group will receive post-operative exercise training and will be encouraged to move. The study group will receive a core stabilization program in addition to education via telerehabilitation. The first evaluation will be performed 2 months post-operatively and the second evaluation will be performed 2 months after treatment.

Conditions

Lumbar Spine Disease

Outcome Measures

Primary Outcomes (8)

• Visual Analog Scale (VAS)

  On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).

  Change from Baseline VAS at 8 weeks

• Tampa Scale for Kinesiophobia (TSK)

  The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.

  Change from Baseline TSK at 8 weeks

• Pain Catastrophising Scale (PCS)

  Scale is used to assess the patient's feelings and thoughts about pain and disaster. The total score ranges from 0 to 52 points. A high score indicates a bad situation.

  Change from Baseline PCS at 8 weeks

• Roland Morris Disability Questionnaire (RMDQ)

  The RMDQ is a self-administered questionnaire consisting of 24 items reflecting various activities of daily living. Each item is scored 1 if it is declared applicable to the participant and 0 otherwise, so that the total score can range from 0 (no disability) to 24 (severe disability).

  Change from Baseline RMDQ at 8 weeks

• Lumbar region flexibility in flexion extension lateral flexion directions

  The subject stands on a block and then performs lumlal flexion with knees straight. The distance above the block with the finger is recorded with a negative sign and the distance below the block is recorded with a positive sign. The subject stands in front of a wall. The pelvis and trunk should be in contact with the wall. The subject is asked to perform lumbar extension. The distance between the sternal notch and the wall is measured and noted. The subject stands in front of a wall with hands next to the trunk. The subject is asked to perform lumbar lateral flexion. The distance from the first position to the last position is measured using the middle finger as a base and noted.

  Change from Baseline flexibilty tests at 8 weeks

• Lumbar region endurance flexor and extensor

  The participant is placed prone on a treatment bed with the upper edge of the iliac crests flush with the edge of the bed. The lower body is secured to the bed with two straps. At the beginning of the test, participants cross their arms over their chest and remain in a neutral position for as long as possible. The time the position can be maintained is measured using a stopwatch. Participants are held in a supine position with both hips and knees flexed 90 degrees and the trunk flexed 60 degrees on a wedge. Stabilization is achieved with support from the back of the foot. After the wedge is moved back 10 cm, the participants maintain their body position for as long as possible. The time from the moment the wedge is moved back to the moment the participant re-establishes contact with the wedge is measured.

  Change from Baseline endurance tests at 8 weeks

• Functional Reach Test (FRT)

  The subject stands sideways next to a wall and flexes the shoulder 90 degrees. The 3rd metacarpal level is marked on the wall. The subject reaches as far as he/she can without taking a step. The 3rd metacarpal line is marked again. The difference between the marks is measured and noted.

  Change from Baseline FRT at 8 weeks

• Stair Climbing Test (SCT)

  The time (in seconds) taken to ascend and descend one flight of stairs is noted. A 9-step ladder with a 20 cm step height and a handrail is used. You are instructed to ascend and descend the stairs as quickly but safely as possible. The use of a handrail and walking aid is allowed if necessary. Timing starts with the start signal and ends when the participant has lowered both feet to ground level. The participant can stop and rest if necessary, but the timing continues.

  Change from Baseline SCT at 8 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

This program will include reeducation isometric contraction exercises for transversus obdominus, oblique abdominals, multifidus lumborum muscles and strengthening stretching exercises for other extremities. These interventions will be sent to the patients via telerehabitation method and the patients will always have access to the programs and training.

Other: Rehabilitation

Control Group

ACTIVE COMPARATOR

The control group will receive post-operative exercise training and will be encouraged to move as described by Moseley et al., 2004.

Other: Control

Interventions

Rehabilitation OTHER

The study group will be given a core stabilization program in addition to education.

Intervention Group

Control OTHER

The control group will receive post-operative cognitive training and will be encouraged to move.

Control Group

Eligibility Criteria

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

You may qualify if:

• Having undergone lumbar decompression surgery without fusion and 2 months of history
• Participate in all necessary follow-up assessments
• Being between 18-65 years old
• Understand simple commands
• Signing the consent form

You may not qualify if:

• Presence of a previous spinal fusion surgery
• Presence of malignancy
• Having undergone spine surgery before
• Have any other orthopedic or neurological problem that may affect treatment and assessments
• Situations that prevent communication
• Lack of cooperation during the study

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Bursa Çekirge State Hospital

Bursa, Osmangazi, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spinal Diseases

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Fatih Özden, PhD

  Muğla Sıtkı Koçman University

  STUDY DIRECTOR

• Mustafa Yalçın, MSc

  Bursa Çekirge State Hospital

  PRINCIPAL INVESTIGATOR

• Baki Umut Tuğay, PhD

  Muğla Sıtkı Koçman University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 28, 2023
• Study Start: June 14, 2023
• Primary Completion: April 10, 2024
• Study Completion: April 15, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

TU (1)