Effects of primal reflex release technique and stretching exercises on
pain and function in patients with coccydynia.
Design
A randomized controlled not blind trial. Sample size 46 divided in 2 groups. Total 12 treatment sessions will be given to subjects.
Settings and conduct
Setting: District Head Quarter (DHQ) Hospital, Sargodha.
Participants/Inclusion and exclusion criteria
1) pain in or around coccyx without radiation
2) tenderness on palpation over coccyx
3) age group above 20 including both male and females
4) difficulty in pain free sitting for long duration
Exclusion
1) Patients with cancer or cysts in pelvic area
2) Any tumor, surgery or fracture, recent trauma
3) Pain in coccyx region referred from lumbar spine, pelvic floor muscles, degenerative disc, bony spurs, cysts, or infections etc.
4) neurologic signs/conditions, sensory paresthesia or motor paresis.
Intervention groups
Patients will be randomly divided into two groups with 23 patients in each group. After taking baseline assessment both group A and B will be treated with hot pack for 10 minutes and then PRRT will be performed. Maximal muscle contraction for 10 seconds
against manual force will be applied in a diagonal of hip flexion adduction followed by relaxation of 30 seconds. 1 set of 6 repetitions of contract relax each treatment session and 3 sessions/week on alternate days will be given for 4 weeks. Stretching will be performed for piriformis and iliopsoas for group B. 3 sessions/week on alternate days will be given for 4 weeks. Treatment time of each session will be approximately 20-25 minutes.
Comparison of Primal Reflex Release Technique and Stretching Exercises in Coccydynia
Public title
Comparison of Primal Reflex Release Technique and Stretching Exercises in Coccydynia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pain in or around coccyx without radiation
Tenderness on palpation over coccyx
Age group above 20 including both male and females
Difficulty in pain free sitting for long duration
Exclusion criteria:
Patients with cancer or cysts in pelvic area
Any tumor, surgery or fracture, recent trauma
Pain in coccyx region referred from lumbar spine, pelvic floor muscles, degenerative disc, bony spurs, cysts, or infections etc.
Pregnancy and coccyx dislocation
If any overt neurologic signs/conditions, such as sensory paresthesia or motor paresis, present during the initial evaluation
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Written informed consent will be taken. After enrollment into study, patient will be allocated either to Group A or Group B by lottery method. No. of Chits will be equal to
total sample size, odd Numbers will be allocated to Group A and even number will be allocated to Group B. Each patient will be requested to draw a chit from the box and after that patient will be recruited into either Group A or Group B.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sargodha Institute of Health Sciences(SIHS) Research Ethical Committee (REC)
Street address
117-C, Zafar Ullah Road, Satellite Town, Sargodha
City
Sargodha
Postal code
40100
Approval date
2021-07-17, 1400/04/26
Ethics committee reference number
SIHS/21/160
Health conditions studied
1
Description of health condition studied
Coccygodynia, is also referred as coccydynia, coccygeal neuralgia, coccalgia, or tailbone pain, is the term that describes the symptoms of pain occurring in the coccyx region. During sitting position pain is most commonly started , but may happen if individual changes his position from sitting to standing. Conservative, manual, surgical and other treatments are used to treat coccydynia depending on severity of condition.
ICD-10 code
M53.3
ICD-10 code description
Sacrococcygeal disorders, not elsewhere classified
Primary outcomes
1
Description
Pain
Timepoint
Before treatment, after treatment (4 weeks)
Method of measurement
Numeric Pain Rating Scale (NPRS)
2
Description
Functional performance
Timepoint
Before treatment, after treatment (4 weeks)
Method of measurement
Dallas Pain Questionnaire (DPQ)
3
Description
Pain
Timepoint
Before treatment, after treatment (4 weeks)
Method of measurement
Pain free sitting duration
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After taking baseline measures, Group A will be treated with hot pack for 10 minutes. A gluteal set will be performed while the physical therapist karate chops the gluteal musculature bilaterally from the sacrum to the coccyx. The first coccyx release technique will be performed 10 times for duration of 30 seconds each treatment session. In second coccyx release technique maximal muscle contraction for 10 seconds against manual force applied in a diagonal of hip flexion adduction. The patient relaxes for 30 seconds. Thus, the contract-relax ratio will be 10:30. It will be performed at 1 set of 6 repetitions of contract relax each treatment session
Category
Treatment - Other
2
Description
Intervention group: After taking baseline measures group B will be treated with hot pack for 10 minutes. Stretching will be performed for Piriformis and Iliopsoas. It will be applied 5 times alternately for both sides for 30 second each with 10 second relaxation between each application.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
District Head Quarter (DHQ) Hospital, Sargodha.
Full name of responsible person
Pakeeza Seemal
Street address
Khushab Road، Sargodha, Punjab
City
Sargodha
Postal code
40100
Phone
+92 48 3215548
Email
pakeezaseemal212@gamil.com
Web page address
https://www.punjab.gov.pk/node/880
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
District Head Quarter (DHQ) Hospital, Sargodha.
Full name of responsible person
Pakeeza Seemal
Street address
Khushab Road، Sargodha, Punjab
City
Sargodha
Postal code
40100
Phone
+92 48 3215548
Email
pakeezaseemal212@gmail.com
Web page address
https://www.punjab.gov.pk/node/880
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
District Head Quarter (DHQ) Hospital, Sargodha
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Sargodha Institute of Health Sciences (SIHS)
Full name of responsible person
Pakeeza Seemal
Position
Senior lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House# 411, street#07, Al Farooq colony, Sargodha.
City
Sargodha
Province
Punjab
Postal code
40100
Phone
+92 48 3726938
Email
pakeezaseemal212@gmail.com
Web page address
https://www.punjab.gov.pk/node/880
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sargodha Institute of Health Sciences (SIHS)
Full name of responsible person
Pakeeza Seemal
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House# 411, street#07, Al Farooq colony, Sargodha.
City
Sargodha
Province
Punjab
Postal code
40100
Phone
+92 48 3726938
Email
pakeezaseemal212@gmail.com
Web page address
https://www.punjab.gov.pk/node/880
Person responsible for updating data
Contact
Name of organization / entity
Sargodha Institute of Health Sciences (SIHS)
Full name of responsible person
Pakeeza Seemal
Position
Senior lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Khushab Road، Sargodha, Punjab
City
Sargodha
Province
Punjab
Postal code
40100
Phone
+92 48 3726938
Email
pakeezaseemal212@gmail.com
Web page address
https://www.punjab.gov.pk/node/880
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further decision and information decided yet
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available