Coccyx DisorderNCT05969769
Effect of Thoracic Mobilization in Females With Coccydynia
A study testing Thoracic Sustained Natural Apophyseal Glides and Muscle Energy Techniques in people with Coccyx Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
Coccydynia is common and prevalent among the females and several types of exercises and electrotherapy are advised. Pain can reduced significantly with both short wave diathermy and muscles stretches. There is limited evidence on indirect method like thoracic mobilization techniques to improve coccydynia. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Coccyx Disorder
- What is being tested?
- Thoracic Sustained Natural Apophyseal Glides and Muscle Energy Techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed females coccydynia patients.
Who cannot join
- Pregnancy
- 6 Months past Surgery, fracture or dislocation of coccyx.
- Malignancy or cyst in the pelvic area.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Rahman Medical Hospital
Peshawar, KPK
summra andleeb, MS(0MPT), 03450617872, sammra.andleeb@riphah.edu.pk
Laiba Zahid, MS(WHPT)
About this study
Official title: Effects of Thoracic Manual Mobilization Techniques in Females of Coccydynia
Coccydynia is common and prevalent among the females and several types of exercises and electrotherapy are advised. Pain can reduced significantly with both short wave diathermy and muscles stretches. There is limited evidence on indirect method like thoracic mobilization techniques to improve coccydynia. This study will determine the effects of thoracic mobilization techniques on coccydynia.
Read the detailed description
Coccydynia, refers to pain in the coccyx region. it can be caused by various factor including trauma or injury (such as falls or child birth ), repetitive strain, prolong sitting on hard surface, or even idiopathic reasons. Treatment options for Coccydynia may include conservative measures, such as pain medication, using cushion or donut-shaped pillows to relieve pressure, applying heat or cold packs, and avoiding activities that's exacerbate the pain. Physical therapy including exercises such as stretching, Muscle Energy Technique (MET) can also be beneficial in some cases. Thoracic manual therapy, which involves hands-on techniques applied to the thoracic spine, can indeed be beneficial for improving spine mobility. While it may not directly target the coccyx itself, improving overall spinal mobility can have indirect effects on coccyx pain and dysfunction.
- Conditions
- Coccyx Disorder
- Being tested
- Thoracic Sustained Natural Apophyseal Glides, Muscle Energy Techniques
- Keywords
- Coccyx Disorder, thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Sustained Natural Apophyseal GlidesOther
Sustained Natural Apophyseal Glides 3 sets of 10 reps with 1 min rest btw sets.
Muscle Energy TechniquesOther
Short wave diathermy for 10 to 15 mins Muscle Energy Techniques of following muscles will be performed, Hip flexors muscles, Quadrates lamborum muscles, Erector spinae muscles, Piriformis muscles, PFS technique of METs Isometric hold 5-7 sec, Stretching 15 sec, Rest 30 sec.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Active comparator | Sustained Natural Apophyseal Glides will be performed with Muscle Energy Technique and Short Wave Diathermy as experimental group. Receives: Other: Thoracic Sustained Natural Apophyseal Glides |
| Control Group | Active comparator | Short wave diathermy will be given with Muscle Energy Techniques. Receives: Other: Muscle Energy Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
Changes from the baseline Numeric Pain Rating Scale will be used to assess pain. • The Numeric Pain Rating Scale is an eleven-point measure of pain: the patient rates pain from 0 (no pain) to 10 (worst imaginable pain). The NPRS has shown good responsiveness in shoulder pain.
Measured: 8th Week
Modified OSWESTRY Low Back pain Index
Changes from the baseline ODI is a disease specific disability measure is used to establish a level of disability stage on a patient activity status and monitor change over the time. The ODI is made up of 10 questions. Each question is scored from (o-5) m
Measured: 8th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Aug 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coccyx DisorderStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- summra andleeb, MS(OMPT), Principal investigator, riphah internation university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969769
- Sponsor's protocol ID
- Laiba Zahid
- Status last verified
- Aug 2023
- First submitted
- 23 Jul 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thoracic Manual Mobilization Techniques in Females of Coccydynia
- ClinicalTrials.gov ID
- NCT05969769
- Acronym / sponsor ID
- Laiba Zahid
- Conditions
- Coccyx Disorder
- Keywords
- Coccyx Disorder, thoracic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coccydynia is common and prevalent among the females and several types of exercises and electrotherapy are advised. Pain can reduced significantly with both short wave diathermy and muscles stretches. There is limited evidence on indirect method like thoracic mobilization techniques to improve coccydynia. This study will determine the effects of thoracic mobilization techniques on coccydynia.
Detailed description
Coccydynia, refers to pain in the coccyx region. it can be caused by various factor including trauma or injury (such as falls or child birth ), repetitive strain, prolong sitting on hard surface, or even idiopathic reasons. Treatment options for Coccydynia may include conservative measures, such as pain medication, using cushion or donut-shaped pillows to relieve pressure, applying heat or cold packs, and avoiding activities that's exacerbate the pain. Physical therapy including exercises such as stretching, Muscle Energy Technique (MET) can also be beneficial in some cases. Thoracic manual therapy, which involves hands-on techniques applied to the thoracic spine, can indeed be beneficial for improving spine mobility. While it may not directly target the coccyx itself, improving overall spinal mobility can have indirect effects on coccyx pain and dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Active comparator | Other: Thoracic Sustained Natural Apophyseal GlidesSustained Natural Apophyseal Glides will be performed with Muscle Energy Technique and Short Wave Diathermy as experimental group. |
| Control Group | Active comparator | Other: Muscle Energy TechniquesShort wave diathermy will be given with Muscle Energy Techniques. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosed females coccydynia patients.
Key exclusion criteria (3 listed)
- Pregnancy
- 6 Months past Surgery, fracture or dislocation of coccyx.
- Malignancy or cyst in the pelvic area.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic Sustained Natural Apophyseal GlidesSustained Natural Apophyseal Glides 3 sets of 10 reps with 1 min rest btw sets. | Other | Experimental Group |
| Muscle Energy TechniquesShort wave diathermy for 10 to 15 mins Muscle Energy Techniques of following muscles will be performed, Hip flexors muscles, Quadrates lamborum muscles, Erector spinae muscles, Piriformis muscles, PFS technique of METs Isometric hold 5-7 sec, Stretching 15 sec, Rest 30 sec. | Other | Control Group |
Primary outcome
Numeric Pain Rating Scale
Time frame: 8th Week
Changes from the baseline Numeric Pain Rating Scale will be used to assess pain. • The Numeric Pain Rating Scale is an eleven-point measure of pain: the patient rates pain from 0 (no pain) to 10 (worst imaginable pain). The NPRS has shown good responsiveness in shoulder pain.
Modified OSWESTRY Low Back pain Index
Time frame: 8th Week
Changes from the baseline ODI is a disease specific disability measure is used to establish a level of disability stage on a patient activity status and monitor change over the time. The ODI is made up of 10 questions. Each question is scored from (o-5) m
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Coccyx Disorder
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Analgesic Efficacy of Capsaicin 8% Patch (QUTENZA®) in Coccygodygnia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
summra andleeb, MS(OMPT) principal investigator
riphah internation university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic Sustained Natural Apophyseal Glides and Muscle Energy Techniques in people with Coccyx Disorder, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact imran amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: 8th Week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.