Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538818
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Ultra Phonophoresis With a Hyaluronic Acid-Containing Gel on Carpal Tunnel Syndrome Post Mastectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ultra Phonophoresis With a Hyaluronic Acid-Containing Gel on Carpal Tunnel Syndrome Related Hormonal Therapy Post Mastectomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study 60 patients will be randomly assigned into two equal groups 30 patients for each group
1 Group A This group will include 30 patients who will receive Ultra Phonophoresis with a hyaluronic acid-containing gel 5 sessions per week for 3 weeks in addition to their physical therapy program and medical treatment
2 Group B This group will include 30 patients who will receive only their traditional physical therapy program and medical treatment
1 Group A This group will include 30 patients who will receive Ultra Phonophoresis with a hyaluronic acid-containing gel 5 sessions per week for 3 weeks in addition to their physical therapy program and medical treatment
2 Group B This group will include 30 patients who will receive only their traditional physical therapy program and medical treatment
Detailed Description:
Criteria for the patient selection
A Inclusion Criteria
The subject selection will be according to the following criteria
Age range between 40-55 years
Female patients will participate in the study
All patients will have hormonal therapy at least for 6 weeks
All patients enrolled to the study will have their informed consent
Patient referred from physician by carpal tunnel syndrome B Exclusion Criteria
The potential participants will be excluded if they meet one of the following criteria
Marked lymphedema
Steroid injection for CTS
Thrombosis propensity
Cervical radiculopathy
Brachial plexopathy
1 Assessment measures and procedures
The outcome measures will include Median nerve sensory and motor distal latency arm volume calculated by circumference measurement pain using a visual analogue scale VAS and Boston Carpal Tunnel Questionnaire BCTQ Assessment will conducted by a physiotherapist pre-and post-treatment
1 Nerve conduction studies
Electro diagnostic assessment will conducted by a physical medicine specialist During the study the temperature of patients hands will be kept 32 For assessing the Motor distal latency the active recording electrode will be fastened on abductor pollicis brevis APB muscle and median nerve will be stimulated at wrist region with stimulator electrode 8 cm proximal to the active electrode and then the distal latency will be recorded Regarding the sensory distal latency the recorder will be fastened on the third finger and stimulator electrode will be placed 14 cm proximal to the recorder and will stimulate median nerve once at wrist and once at palm region then distal latency will be recorded Normal distal sensory latency of median nerve is of less than 36 and distal motor latency of median nerve less than 42 If only the sensory distal latency will long patient has mild CTS but if both sensory and motor distal latency will be long and denervation will not be observed in electromyography of APB it is moderate CTS Dumitru et al 2002
2 Visual analogue scale VAS for pain assessment
Intensity of pain is another outcome measure will be used to evaluate treatment Adults use the visual analogue scale VAS a one-dimensional assessment tool particularly for chronic pain The VAS is a continuous scale that consists of a line that is either vertical VVAS or horizontal HVAS usually 10 cm long and is supported by two verbal descriptors one for each symptom intensity The patients will be thoroughly briefed on the instructions reporting timeline and vocal description anchors prior to the measurement Hawker et al 2011
3 Baseline hand dynamometer Baseline hydraulic hand dynamometer is used to measure hand grip strength It is manufactured and serviced in the USA since 1978 It gives accurate grip strength readings without the subject being able to feel the handle move
The internationally accepted design ensures reliability user convenience and measurement repeatability Maximum reading remains until the unit is reset The device comes with five position handles to improve comfort while using the dynamometer The device Gauge is made of bourdon tube element with spring suspended movement that can viewed as pounds or kilograms Helen et al 2011
4 Boston Carpal Tunnel Questionnaire BCTQ
Patients w Patients with CTS can assess their level of dysfunction and symptom severity using the BCTQ It has two measurement scales the BCTQ-F which measures functional status and the BCTQ-S which measures symptom severity The BCTQ-S employs eleven questions on a five-point rating system from 1 no symptoms to 5 severe symptoms to assess the frequency and intensity of pain numbness weakness and loss of dexterity The average scores of the 11 questions are used to analyze the results The BCTQ-F has eight questions that are scored on a five-point scale from 1 no trouble to 5 cannot do at all owing to hand or wrist symptoms to assess the degree of difficulty in carrying out daily chores The average scores of the eight questions are used to analyze the results Levine et al 1993
2-2- 50 - 100 b-Therapeutic device aUltrasound device Gel pad Phyactio n For ultrasound therapy offers a large and clear screen with a user-friendly interface that makes it simple and easy to use The device comes with a multi-frequency detachable head 1 3 MHZ and offers different pulsed and continuous modes 10 -25 - 30 - 40 - 50 - 100
Device specifications
-Dimensions 265 x 275 x 122 mm
-Weight 31 Kg
-Mains voltage 100 - 240 VAC 5060 HZ
-Maximum power 35 VA
-Safety class Class I
-Treatment time 0-30 minutes
2 Procedures of Ultra Phonophoresis Therapeutic pulsed ultrasound using Phyaction UbMF ultrasound device in presence of a hyaluronic acid-containing gel will be applied gel pad over the wrist and along the course of median nerve at the carpal tunnel
The following parameters will be used intensity of 10 Wem2 at a 1MHz frequency for 5 minutes and pulsed 25 ultrasound waves to transfer the hyaluronic acid-containing gel This therapy will be applied for 5 minsession 5 dwk for 3 weeks
The following parameters will be used
intensity of 10 Wcm2
1MHz frequency
pulsed 25
5 minsession 5 dwk for 3 weeks
A Inclusion Criteria
The subject selection will be according to the following criteria
Age range between 40-55 years
Female patients will participate in the study
All patients will have hormonal therapy at least for 6 weeks
All patients enrolled to the study will have their informed consent
Patient referred from physician by carpal tunnel syndrome B Exclusion Criteria
The potential participants will be excluded if they meet one of the following criteria
Marked lymphedema
Steroid injection for CTS
Thrombosis propensity
Cervical radiculopathy
Brachial plexopathy
1 Assessment measures and procedures
The outcome measures will include Median nerve sensory and motor distal latency arm volume calculated by circumference measurement pain using a visual analogue scale VAS and Boston Carpal Tunnel Questionnaire BCTQ Assessment will conducted by a physiotherapist pre-and post-treatment
1 Nerve conduction studies
Electro diagnostic assessment will conducted by a physical medicine specialist During the study the temperature of patients hands will be kept 32 For assessing the Motor distal latency the active recording electrode will be fastened on abductor pollicis brevis APB muscle and median nerve will be stimulated at wrist region with stimulator electrode 8 cm proximal to the active electrode and then the distal latency will be recorded Regarding the sensory distal latency the recorder will be fastened on the third finger and stimulator electrode will be placed 14 cm proximal to the recorder and will stimulate median nerve once at wrist and once at palm region then distal latency will be recorded Normal distal sensory latency of median nerve is of less than 36 and distal motor latency of median nerve less than 42 If only the sensory distal latency will long patient has mild CTS but if both sensory and motor distal latency will be long and denervation will not be observed in electromyography of APB it is moderate CTS Dumitru et al 2002
2 Visual analogue scale VAS for pain assessment
Intensity of pain is another outcome measure will be used to evaluate treatment Adults use the visual analogue scale VAS a one-dimensional assessment tool particularly for chronic pain The VAS is a continuous scale that consists of a line that is either vertical VVAS or horizontal HVAS usually 10 cm long and is supported by two verbal descriptors one for each symptom intensity The patients will be thoroughly briefed on the instructions reporting timeline and vocal description anchors prior to the measurement Hawker et al 2011
3 Baseline hand dynamometer Baseline hydraulic hand dynamometer is used to measure hand grip strength It is manufactured and serviced in the USA since 1978 It gives accurate grip strength readings without the subject being able to feel the handle move
The internationally accepted design ensures reliability user convenience and measurement repeatability Maximum reading remains until the unit is reset The device comes with five position handles to improve comfort while using the dynamometer The device Gauge is made of bourdon tube element with spring suspended movement that can viewed as pounds or kilograms Helen et al 2011
4 Boston Carpal Tunnel Questionnaire BCTQ
Patients w Patients with CTS can assess their level of dysfunction and symptom severity using the BCTQ It has two measurement scales the BCTQ-F which measures functional status and the BCTQ-S which measures symptom severity The BCTQ-S employs eleven questions on a five-point rating system from 1 no symptoms to 5 severe symptoms to assess the frequency and intensity of pain numbness weakness and loss of dexterity The average scores of the 11 questions are used to analyze the results The BCTQ-F has eight questions that are scored on a five-point scale from 1 no trouble to 5 cannot do at all owing to hand or wrist symptoms to assess the degree of difficulty in carrying out daily chores The average scores of the eight questions are used to analyze the results Levine et al 1993
2-2- 50 - 100 b-Therapeutic device aUltrasound device Gel pad Phyactio n For ultrasound therapy offers a large and clear screen with a user-friendly interface that makes it simple and easy to use The device comes with a multi-frequency detachable head 1 3 MHZ and offers different pulsed and continuous modes 10 -25 - 30 - 40 - 50 - 100
Device specifications
-Dimensions 265 x 275 x 122 mm
-Weight 31 Kg
-Mains voltage 100 - 240 VAC 5060 HZ
-Maximum power 35 VA
-Safety class Class I
-Treatment time 0-30 minutes
2 Procedures of Ultra Phonophoresis Therapeutic pulsed ultrasound using Phyaction UbMF ultrasound device in presence of a hyaluronic acid-containing gel will be applied gel pad over the wrist and along the course of median nerve at the carpal tunnel
The following parameters will be used intensity of 10 Wem2 at a 1MHz frequency for 5 minutes and pulsed 25 ultrasound waves to transfer the hyaluronic acid-containing gel This therapy will be applied for 5 minsession 5 dwk for 3 weeks
The following parameters will be used
intensity of 10 Wcm2
1MHz frequency
pulsed 25
5 minsession 5 dwk for 3 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None