1. Home
  2. Approved trials
  3. » فارسی

The Effectiveness of Flexion Exercises and Manual Therapy on the Functional Disability of Patients with Lumbar Spinal Canal Stenosis

Protocol summary

Study aim
This study aims to determine the effectiveness of flexion exercises and manual therapy on functional disability, the amount of pain and discomfort in the legs/feet, and the walking ability of patients with lumbar spinal stenosis.
Design
A randomized, controlled, blinded, parallel group clinical trial with 60 patients, using Random Allocation Software.
Settings and conduct
The patients referred to the physiotherapy clinic of Beheshti Hospital by the neurosurgeon, and after taking a medical history, meeting the criteria, and consenting, will be included. Variables are measured pre-treatment, then the patients will be randomly assigned to either the intervention or control groups and will be treated for 18 sessions. Post-treatment re-evaluation will be used to determine the effectiveness of treatments.
Participants/Inclusion and exclusion criteria
Patients over 50 with back, hip or leg pain, sensory disturbance and muscle weakness for at least the last 3 months, worsened by standing and walking and relieved by sitting, will be included. Exclusions: severe spinal canal stenosis; history of surgery/epidural injection in the lumbar region; exercise prohibition or intolerance; vertebral compression fracture; scoliosis; cognitive disorders; history of malignancy; severe osteoporosis; severe peripheral vascular disorders/heart disease; spondylolisthesis; neurological diseases that affect the patient's walking; inability to walk for reasons except spinal stenosis; diabetic neuropathy; pain level higher than 7 based on VAS scale
Intervention groups
Both groups will receive electrotherapy and flexion exercises. The intervention group will also receive manual therapy including massage, lumbar joints and nerve mobilization, and soft tissue stretching.
Main outcome variables
Primary: functional disability index Secondary: the amount of pain and discomfort in the legs and feet; ability to walk

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091214002851N8
Registration date: 2024-08-22, 1403/06/01
Registration timing: prospective

Last update: 2024-08-22, 1403/06/01
Update count: 0
Registration date
2024-08-22, 1403/06/01
Registrant information
Name
Mohammad Taghipour
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 4641
Email address
taghipour@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-06, 1403/06/16
Expected recruitment end date
2025-01-05, 1403/10/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Flexion Exercises and Manual Therapy on the Functional Disability of Patients with Lumbar Spinal Canal Stenosis
Public title
Effect of Flexion Exercises and Manual Therapy in Lumbar Spinal Canal Stenosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pain, Sensory Disturbance, Muscle Weakness in the Low Back, Buttock or Leg that is Aggravated by Standing and Walking and Alleviated by Sitting Confirmation of Spinal Canal Stenosis at the Lower Lumbar Level in MRI Images by a Specialist Doctor Age over 50 Years The Presence of Clinical Symptoms, at least in the Last 3 Months
Exclusion criteria:
Severe Spinal Stenosis (Grades C and D of the Schizas Diagnostic Criteria) that is a Candidate for Surgery History of Low Back Surgery Severe Heart Disease Prohibition or Intolerance of Exercises by the Patient (Pregnant Women, Patients with Abdominal Surgery, ...) History of Epidural Injection in the Lumbar Region Compression Fracture in the Vertebra Clear Scoliosis Cognitive Disorders History of Malignancy Severe Osteoporosis (T score < -2.5) Severe Peripheral Vascular Disorders Spondylolisthesis Neurological Diseases that Affect the Patient's Walking Inability to Walk for Reasons other than Spinal Stenosis (Severe Osteoarthritis of the Hip or Knee, ...) Diabetic Neuropathy that Has Been Diagnosed Based on the Doctor's Clinical Examination and EMG and NCV Studies Pain Level Higher than 7 Based on VAS Scale
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: In this parallel randomized clinical trial study, taking into account that not all patients are included in the study at the same time, and the researchers cannot predict which group each patient will belong to, in order to assign each patient to one of the two groups, the block randomization method will be used. In order to hide the random assignment, the codes created by the software will be placed in opaque envelopes so that it is not clear which group the next person will be assigned to. In this study, the eligible participating patients, after receiving informed consent, according to the block randomization protocol (produced by Random Allocation Software) were allocated to one of the two control and intervention groups with a ratio of 1:1 and in blocks of 6 in such a way that the researcher cannot predict which group the next person will be placed in. The codes will be placed in the opaque envelopes, and with the entry of each new person, the envelope will be opened and the person's belonging to the relevant group will be determined. Allocation Concealment: In order to hide the random allocation, the codes created by the software will be placed in opaque envelopes so that the next person to be assigned to each group is not known. Based on the sample size of this study, a number of opaque envelopes (to avoid clarity of the contents of the envelopes) are prepared and each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain random order, the outer surface of the envelopes is numbered in the same order. Finally, the lids of the envelopes are glued and placed in a box. At the beginning of registration, based on the order of entry of eligible participants into the study, one of the letter envelopes will be opened in order and the allocated group of that participant will be revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be conducted in a single-blind manner. In this way, the evaluator will be completely unaware of which group the patients belong to in order to measure the results.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganj Afrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2024-08-10, 1403/05/20
Ethics committee reference number
IR.MUBABOL.HRI.REC.1403.062

Health conditions studied

1

Description of health condition studied
lumbar spinal canal stenosis
ICD-10 code
M48.06
ICD-10 code description
Spinal stenosis, lumbar region

Primary outcomes

1

Description
Functional Disability Index
Timepoint
Before starting and after the end of 6 weeks of intervention
Method of measurement
It is measured by the Persian Modified Oswestry Disability Index questionnaire

Secondary outcomes

1

Description
The amount of pain and discomfort in the leg and foot area of patients
Timepoint
Before starting and after the end of 6 weeks of intervention
Method of measurement
Visual Analogue Scale

2

Description
Walking Ability
Timepoint
Before starting and after the end of 6 weeks of intervention
Method of measurement
self-paced walking Test

Intervention groups

1

Description
Control group: In each treatment session, 20 minutes of infrared lamp on the lower back area and 20 minutes of high TENS with two channels with a frequency of 100-150 Hz, pulse duration of 50-80 microseconds, and current intensity to the level of a strong and comfortable feeling of current on both sides of the lower back area and also the lower limb of the involved side will be used for the patient. Also, in the first session, exercises will be taught to the patient and pictures related to each exercise will be provided to him to perform at home. Then the patient is asked to do each of the exercises three times a day in three sets of ten. In each visit, the patient is asked to do three sets of ten exercises in the clinic in order to make sure that the exercises are done correctly and if necessary, the exercises can be modified or re-educated. Exercises include lumbar spine flexion range of motion exercises in the supine position (using the knee to chest movement), in the prone position (by lying on your stomach on one or more pillows or a large ball), in the sitting position (by bending forward from the short sitting position and resting the hands on a table in front of the patient) and in the quadruped position (with backward rocking movement), stretching of the hip flexors, posterior tilt of the pelvis in the position of crook lying and trunk curl. Based on the evaluation of the patient's response to the exercises, the exercises will be adjusted if necessary.
Category
Rehabilitation

2

Description
Intervention group: In this group, in addition to the treatments of the control group, manual therapy including mobilization of soft tissue, joints and nerves and stretching techniques will also be used. First, the patient will lie down in the prone position while a pillow is placed on his abdomen, and a stroking/petrisage massage of the lumbar region will be performed for him for 5 minutes. Central posterior-anterior pressure mobilization techniques on spinous processes or one-sided on the facet joints (depending on individual symptoms) in the prone position, lumbar rotation-mobilization (in the crook-lying position using knee levers) and lumbar flexion-distraction mobilization in the supine position (while the knee is flexed, the therapist places the other hand in the sacrum region and simultaneously with the lumbar flexion, by applying force towards the caudal side, the distraction force will be performed) will be performed for 5 minutes. Mobilization techniques will be performed in 3 sets and 30 seconds of rest will be considered between techniques. Mobilization of the sciatic nerve (using sliding and tension techniques) will be done in standard positions and with grading according to the patient's conditions for 5 minutes (3 sets with 15 repetitions) depending on the severity of nerve involvement. At the end of the therapeutic session, passive stretching of back extensor muscles (knee to chest) and hip flexor muscles (in supine position) will be done for 5 minutes for the patient.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy clinic of Shahid Beheshti hospital
Full name of responsible person
Mohammad Taghipour
Street address
Keshvari Square, Sargord Ghasemi St., Shahid Beheshti Hospital, Physiotherapy Center
City
Babol
Province
Mazandaran
Postal code
4716681457
Phone
+98 11 3226 0458
Email
beheshti@mubabol.ac.ir
Web page address
https://beheshti.mubabol.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahdi Rajabnia
Street address
Babol University of Medical Sciences, Ganj Afrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647754
Phone
+98 11 3219 7667
Email
research@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Roya Khoshooei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Babol University of Medical Sciences, Ganj Afrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 4641
Email
rkhoshooei@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohammad Taghipour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Babol Medical Sciences University, Ganj Afrooz Ave
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 4641
Email
taghipour@mubabol.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Roya Khoshooei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Babol University of Medical Sciences, Ganj Afrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 4641
Email
rkhoshooei@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can potentially be shared after unidentified individuals.
When the data will become available and for how long
Access period starts 2 months after the results are published
To whom data/document is available
Researchers working in academic, scientific and medical institutions
Under which criteria data/document could be used
To cite other researchers from the results of our research
From where data/document is obtainable
Dr. Mohammad Taghipour, Babol University of Medical sciences, college of rehabilitation 00989126899352, taghipour@mubabol.ac.ir Roya Khoshooei, Babol University of Medical Sciences, college of rehabilitation 00989131078922, rkhoshooei@gmail.com
What processes are involved for a request to access data/document
2-4 weeks after request by email
Comments
Loading...