Protocol summary

Summary
Objective: Comparing the effect of manipulation with and without kinesio taping on pain, disability and endurance of trunk flexor-extensor muscles in 20 to 45 years old athletes with chronic non-specific low back pain Participants: Forty-two athletes (21males, 21females) with non-specific chronic mechanical- low back pain Sampling was done by table of random numbers. Inclusion criteria: suffering from low back pain for at least 3 months before the study; Aged 20_45 years old; doing at least 3 sessions of 2-hours moderate aerobic exercise weekly; pain intensity of at least 30 or more from 100; pain and disability level of at least 8 from 52 Exclusion criteria: neurological diseases; rheumatoid diseases; diabetes; osteoporosis; tumor; trauma; fracture in lower extremities; received physiotherapy in last 3 months or used opioid or analgesic drugs in last 72 hours; pregnant patients; patients with psychological disorders; patients in whom manipulation had contraindication Intervention: Lumbar rotational manipulation and lumbar kinesio taping Main Outcome Measures: Pain intensity, functional disability level and endurance of trunk flexor-extensor muscles were assessed before and after the interventions in different follow-ups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016020624149N5
Registration date: 2016-06-26, 1395/04/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-06-26, 1395/04/06
Registrant information
Name
Fahimeh Kamali
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1551
Email address
kamalif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of manipulation with or without kinesio taping on pain, disability and endurance of trunk flexor-extensor muscles in 20 to 45 years old athletes with chronic non-specific low back pain
Public title
The effects of manipulation and kinesio taping on pain and disability of athletes with chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: suffering from low back pain for at least 3 months before the study; Aged 20_45 years old; doing at least 3 sessions of 2-hours moderate aerobic exercise weekly; pain intensity of at least 30 or more from 100; pain and disability level of at least 8 from 52 Exclusion criteria: neurological diseases; rheumatoid diseases; diabetes; osteoporosis; tumor; trauma; fracture in lower extremities; received physiotherapy in last 3 months or used opioid or analgesic drugs in last 72 hours; pregnant patients; patients with psychological disorders; patients in whom manipulation had contraindication
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice-Chancellery for Research Office, Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Blvd. Shiraz
City
Shiraz
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
CT-92-6831

Health conditions studied

1

Description of health condition studied
non-specific chronic mechanical- low back pain
ICD-10 code
M54.5
ICD-10 code description
low back pain

Primary outcomes

1

Description
Pain intensity
Timepoint
Before, Immediately, A day, A week and A month after intervention
Method of measurement
VAS

2

Description
Disability level
Timepoint
Before, A day, A week and A month after intervention
Method of measurement
Oswestry pain and disability questionnaire

3

Description
Endurance of trunk flexor-extensor muscles
Timepoint
Before, A day, A week and A month after intervention
Method of measurement
Unsupported Trunk Holding, McQuade

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Manipulation
Category
Treatment - Other

2

Description
Intervention group: Manipulation and Kinesio taping
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mofatteh student dormitory
Full name of responsible person
Javad Bujar
Street address
Campus of Shiraz University, Eram St.
City
Shiraz

2

Recruitment center
Name of recruitment center
Zeinab student dormitory
Full name of responsible person
Ms. Moradi
Street address
Abiverdi St. Chamran Blvd.
City
Shiraz

3

Recruitment center
Name of recruitment center
Payam Sport Complex
Full name of responsible person
Hossein Eftekhari
Street address
59 Alley, Ghasrodasht St.
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellery for research affairs, Shiraz University of Medical Sciences
Full name of responsible person
Basir Hashemi
Street address
Central Building of Shiraz University of Medical Sciences, Zand Blvd. Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellery for research affairs, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Rehabilitation Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Fahimeh Kamali
Position
Associate Professor
Other areas of specialty/work
Street address
Abiverdi St. Chamran Blvd. Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
kamalif@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Rehabilitation Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Fahimeh Kamali
Position
Associate Professor
Other areas of specialty/work
Street address
Abiverdi St. Chamran Blvd. Shiraz
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
kamalif@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Rehabilitation Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Fahimeh Kamali
Position
Associate Professor
Other areas of specialty/work
Street address
Abiverdi St. Chamran Blvd. Shiraz
City
Shiraz
Postal code
Phone
00
Fax
Email
kamalif@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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