Ignite Creation Date:
2024-05-06 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03606720
Status:
UNKNOWN
Last Update Posted:
2020-12-10
First Post:
2018-07-14
Brief Title:
Effect of Low Level Laser Therapy and Pelvic Stabilisation Exercises on Postpartum Pelvic Girdle Pain
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Effect of Low-level Laser Therapy and Pelvic Stabilisation Exercises on Postpartum Pelvic Girdle Pain
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PGP
Brief Summary:
This study will be conducted to show the effect of low level laser therapy 810 nm and pelvic stabilization exercises has Effect on pelvic girdle pain Postpartum Pelvic girdle pain PPGP is common complaint in pregnant women all over the world and it has a major impact on health and functioning as it decreases quality of life PGP generally arises in relation with pregnancy trauma and reactive arthritis The onset of PGP is usually by weeks 17-19 of gestation with a peak of incidence by weeks 24- 36 Postpartum follow-up studies have shown that 5- 27 of the women had persisting pain 1-3 months after delivery However it was report that 7 have remaining pain 6 years after delivery causing severe discomfort and reduced ability to work ninety prime-gravid or multigravida postnatal womens were randomly classified into three groups Group A composed of 30 patients who received low-level laser therapy and pelvic stabilization exercises for 12 sessions over six weeks period by 2 sessions per week Group B composed of 30 patients who low-level laser therapy only for 12 sessions over six weeks period by 2 sessions per week and Group C composed of 30 patients who received pelvic stabilization exercises For 12 sessions over six weeks period by 2 sessions per week Pain Using Visual analogue scale serum cortisol level and disability using pelvic girdle questionnaire were measured and compared at 0 and 6 weeks after the treatment in the 3 groups
Detailed Description:
Study design This work were conducted in physical therapy department of Imbaba general Hospital and in outpatient clinic of National Institute of Laser Enhanced Sciences Cairo University Design of the study It is a clinical study Eighteen womens with postpartum pelvic girdle pain was participate in this study and were randomly into three equal groups
Eligibility Criteria
Female participants at least 18 years old Group A composed of 30 patients who low level laser therapy and pelvic stabilization exercises For 12 sessions over six weeks period by 2 sessions per week Group it is the study group B composed of 30 patients who low level laser therapy only for 12 sessions over six weeks period by 2 sessions per week GroupC composed of 30 womens who received pelvic stabilization exercises only For 12 sessions over six weeks period by 2 sessions per week The ethical committee clearance and an informed consent of the subjects will be taken Subjects will have all rights to withdraw from the study at any time without any responsibility
Inclusion criteria
1 Ongoing sacral pain with onset during the preceding pregnancy reported on a present pain drawing
2 Pain intensity 4 cm as worst during the past week on a 10 cm visual analogue scale VAS
3 One positive pain provocation test of either Posterior Pelvic Pain Provocation test Patricks Faber test
4 Provoked pain by a gentle pressure on the ischial spine ipsilateral to reported sacral pain at least unilaterally
Exclusion criteria The criteria for excluding potential research subjects included
1 Nerve root affection in the lumbo-sacral spine
2 Inflammatory disease with pelvic bone andor spinal manifestation
3 Known endometriosis gynecologic cancer or ongoing malign disease
4 Previous surgery of the lumbar spine
5 Incapacity to complete the questionnaires
6 Age 18 years
7 Body mass index 35 kgm2
8 Intolerance to the treatment dose or negative reactions of the laser treatment
9 A new pregnancy during treatment or between the follow-ups Study methods Instrumentation
Low-Level Laser Therapy LLLT parameter
Laser medium Semiconductor - Gallium Aluminum- Arsenide Ga Al As Model manufacture Sundom Laser-Taiwan RG - 300IB Wavelength 810 nm Output power 500 mw20 Mode Continuous Wave CW Spot diameter 10 mm Treatment 12 applications of LLLT will give on a twice weekly Assessment procedures Full medical history including age BMI date of onset medical history will collected and all patients will assessed before and after treatment program
Outcome Measures Primary Outcome Measure
Pain intensity By Visual analogue scale VAS Pain will assessed by using VAS that is a 10 mm calibrated line with zero representing no pain and10 representing worst pain Time Frame Baseline to 6 weeks after treatment Crichton 2001
Secondary Outcome Measures
Posterior pelvic pain provocation test PPPPT Used to determine the presence of sacroiliac dysfunction It is used often in post pregnant women to distinguish between pelvic girdle pain and LBP Time Frame Baseline to 6 weeks after treatment Gutke Hansson et al 2009 FABER Test Patricks test Flexion Abduction and External Rotation These three motions combined result in a clinical pain provocation test to find pathologies at the hip lumbar and sacroiliac region Time Frame Baseline to 6 weeks after treatment Bagwell Bauer et al 2016 Pelvic Girdle Questionnaire The Pelvic Girdle Questionnaire PGQ is a condition-specific measure for women with pelvic girdle pain PGP The PGQ includes items relating to activityparticipation and bodily symptoms and has reliability validity and feasibility for use in research and clinical practice Time Frame Baseline to 6 weeks after treatment Stuge Garratt et al 2011
Serum cortisol level
Cortisol is a hormone secreted by the adrenal gland It is the major corticosteroids It is responsible for about 95 of all glucocorticoids activity in the bodyPool and Axford 2001 It released into our body when we are under stress Cortisol is high in subjects suffering from pain as compared with healthy and pain free subjects as there is positive correction between the intensity of pain and increased plasma cortisol level The blood sample will take for the measurement of plasma cortisol from 9 am to 1 pm Each patient will be drawn two 5 ml blood samples from cubital vein two times Time Frame Baseline to 6 weeks after treatment Thabet Hanfy et al 2008 Treatment procedures Eighteen womens were randomly classified into three groups
Group A study group consist of 30 patients who received Low Level Laser Therapy and Pelvic stabilization exercise for 12 sessions Two sessions per week over six weeks period
A Class IV low-level laser therapy device sundom300IB The device delivers its energy by 2 wavelengths 20 of the beam with 650 nm nanometer and 80 of the beam with 810 nm Energy given will tested before the start of the study and once every 6 months using Thor labs power meter PM100D and the photo sensor S 121 C to make sure the device works correctly The treatment applied to the sacral region by a standard laser probe at the top and to the anterior pelvis The physical therapist and the participant use safety eyewear during all treatment sessions and the treatment administration area is closed have restricted access and no reflective surfaces During treatment at sacral points the standard probe moved 1 cmsecond from a starting point to an end-point repeatedly during treatment time bilaterally Fluency of irradiation of 10 Jcm2 exposure of 100 seconds per point 6 points of irradiation on the pelvic area the standard probe held perpendicular to the body surface and pressed to the skin Monticone Barbarino et al 2004 B Pelvic stablisation exercises as in-group C Group B consist of 30 patients who received Low Level Laser Therapy only for 12 sessions Two sessions per week over six weeks period
Group C control group consist of 30 patients will receive treatment special program of pelvic stabilization exercises only Two sessions per week over six weeks period pelvic stabilizing exercise will done by all patients in the group C depending on exercising of transverse abdominal in addition to co activation of lumbar multifidus muscles at the lumbosacral area exercising of oblique abdominal gluteus Maximus latissimus dorsi muscles quadratus lumborum erector spinae also hip abductors and adductors Mukkannavar 2013The stress was on exercising of transverse abdominal muscles in form of bridging exercise posterior pelvic rocking exercise bilateral hip abduction and adduction exercise hip shrugging and bilateral knees elevation The patient lying on the side kneeling four points sitting and standing The subjects were encouraged to activate the transversely oriented abdominal muscles regularly during daily activities They performed two sets of exercise from 10-15 times firstly 10 times in the 12 sessions after that15 times for the others 12 sessions Rest for 30-second to one minute between each set Home program session performed for 10 minutes twice a day Each session lasted 45 minutes
Eligibility Criteria
Female participants at least 18 years old Group A composed of 30 patients who low level laser therapy and pelvic stabilization exercises For 12 sessions over six weeks period by 2 sessions per week Group it is the study group B composed of 30 patients who low level laser therapy only for 12 sessions over six weeks period by 2 sessions per week GroupC composed of 30 womens who received pelvic stabilization exercises only For 12 sessions over six weeks period by 2 sessions per week The ethical committee clearance and an informed consent of the subjects will be taken Subjects will have all rights to withdraw from the study at any time without any responsibility
Inclusion criteria
1 Ongoing sacral pain with onset during the preceding pregnancy reported on a present pain drawing
2 Pain intensity 4 cm as worst during the past week on a 10 cm visual analogue scale VAS
3 One positive pain provocation test of either Posterior Pelvic Pain Provocation test Patricks Faber test
4 Provoked pain by a gentle pressure on the ischial spine ipsilateral to reported sacral pain at least unilaterally
Exclusion criteria The criteria for excluding potential research subjects included
1 Nerve root affection in the lumbo-sacral spine
2 Inflammatory disease with pelvic bone andor spinal manifestation
3 Known endometriosis gynecologic cancer or ongoing malign disease
4 Previous surgery of the lumbar spine
5 Incapacity to complete the questionnaires
6 Age 18 years
7 Body mass index 35 kgm2
8 Intolerance to the treatment dose or negative reactions of the laser treatment
9 A new pregnancy during treatment or between the follow-ups Study methods Instrumentation
Low-Level Laser Therapy LLLT parameter
Laser medium Semiconductor - Gallium Aluminum- Arsenide Ga Al As Model manufacture Sundom Laser-Taiwan RG - 300IB Wavelength 810 nm Output power 500 mw20 Mode Continuous Wave CW Spot diameter 10 mm Treatment 12 applications of LLLT will give on a twice weekly Assessment procedures Full medical history including age BMI date of onset medical history will collected and all patients will assessed before and after treatment program
Outcome Measures Primary Outcome Measure
Pain intensity By Visual analogue scale VAS Pain will assessed by using VAS that is a 10 mm calibrated line with zero representing no pain and10 representing worst pain Time Frame Baseline to 6 weeks after treatment Crichton 2001
Secondary Outcome Measures
Posterior pelvic pain provocation test PPPPT Used to determine the presence of sacroiliac dysfunction It is used often in post pregnant women to distinguish between pelvic girdle pain and LBP Time Frame Baseline to 6 weeks after treatment Gutke Hansson et al 2009 FABER Test Patricks test Flexion Abduction and External Rotation These three motions combined result in a clinical pain provocation test to find pathologies at the hip lumbar and sacroiliac region Time Frame Baseline to 6 weeks after treatment Bagwell Bauer et al 2016 Pelvic Girdle Questionnaire The Pelvic Girdle Questionnaire PGQ is a condition-specific measure for women with pelvic girdle pain PGP The PGQ includes items relating to activityparticipation and bodily symptoms and has reliability validity and feasibility for use in research and clinical practice Time Frame Baseline to 6 weeks after treatment Stuge Garratt et al 2011
Serum cortisol level
Cortisol is a hormone secreted by the adrenal gland It is the major corticosteroids It is responsible for about 95 of all glucocorticoids activity in the bodyPool and Axford 2001 It released into our body when we are under stress Cortisol is high in subjects suffering from pain as compared with healthy and pain free subjects as there is positive correction between the intensity of pain and increased plasma cortisol level The blood sample will take for the measurement of plasma cortisol from 9 am to 1 pm Each patient will be drawn two 5 ml blood samples from cubital vein two times Time Frame Baseline to 6 weeks after treatment Thabet Hanfy et al 2008 Treatment procedures Eighteen womens were randomly classified into three groups
Group A study group consist of 30 patients who received Low Level Laser Therapy and Pelvic stabilization exercise for 12 sessions Two sessions per week over six weeks period
A Class IV low-level laser therapy device sundom300IB The device delivers its energy by 2 wavelengths 20 of the beam with 650 nm nanometer and 80 of the beam with 810 nm Energy given will tested before the start of the study and once every 6 months using Thor labs power meter PM100D and the photo sensor S 121 C to make sure the device works correctly The treatment applied to the sacral region by a standard laser probe at the top and to the anterior pelvis The physical therapist and the participant use safety eyewear during all treatment sessions and the treatment administration area is closed have restricted access and no reflective surfaces During treatment at sacral points the standard probe moved 1 cmsecond from a starting point to an end-point repeatedly during treatment time bilaterally Fluency of irradiation of 10 Jcm2 exposure of 100 seconds per point 6 points of irradiation on the pelvic area the standard probe held perpendicular to the body surface and pressed to the skin Monticone Barbarino et al 2004 B Pelvic stablisation exercises as in-group C Group B consist of 30 patients who received Low Level Laser Therapy only for 12 sessions Two sessions per week over six weeks period
Group C control group consist of 30 patients will receive treatment special program of pelvic stabilization exercises only Two sessions per week over six weeks period pelvic stabilizing exercise will done by all patients in the group C depending on exercising of transverse abdominal in addition to co activation of lumbar multifidus muscles at the lumbosacral area exercising of oblique abdominal gluteus Maximus latissimus dorsi muscles quadratus lumborum erector spinae also hip abductors and adductors Mukkannavar 2013The stress was on exercising of transverse abdominal muscles in form of bridging exercise posterior pelvic rocking exercise bilateral hip abduction and adduction exercise hip shrugging and bilateral knees elevation The patient lying on the side kneeling four points sitting and standing The subjects were encouraged to activate the transversely oriented abdominal muscles regularly during daily activities They performed two sets of exercise from 10-15 times firstly 10 times in the 12 sessions after that15 times for the others 12 sessions Rest for 30-second to one minute between each set Home program session performed for 10 minutes twice a day Each session lasted 45 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None